Device Firms: What You Should Know About The 21st Century Cures Act

By Mason Weeda

Last month, legislation that would affect, among other things, FDA’s regulation of medical devices and the manufacturers of such devices took a considerable step forward when it was introduced and then unanimously approved by the House Energy and Commerce Committee by a vote of 51-0 on May 21.  Known as the 21st Century Cures Act (“Act”), the stated aim of the legislation is to modernize and personalize health care, encourage innovation, support research, and streamline the U.S. health care system to promote the delivery of better and faster “cures” to more patients.

In support of this goal, the Act would change the review of medical devices determined to be “breakthrough,” establish a third-party option for the inspection of medical device manufacturers, make changes to certain Humanitarian Device Exemption (“HDE“) requirements, institutionalize FDA’s ongoing efforts regarding the regulation of medical software applications, and loosen some clinical investigation requirements.  Significantly, the legislation also indicates an ongoing Congressional interest in the restrictions FDA has placed on the dissemination of truthful and nonmisleading off-label information.

Breakthrough Device Pathway

The Act would support faster “cures” by creating a “priority review” pathway for those devices that meet the definition of a “breakthrough device.”  These “breakthrough devices” include those that “represent breakthrough technologies… for which no approved alternative exist,” offer “significant advantages over existing approved or cleared alternative,” and are “otherwise in the best interest of patients.”

Upon a sponsor’s request, FDA would determine whether a device meets the “breakthrough device” designation using specified criteria.  If a device receives such designation, it would be eligible for expedited review by a team of staff that will interact with the device sponsor.  During this process, the Act would require FDA to “take steps to ensure that the design of clinical trials is as efficient as practicable, such as through adoption of shorter or smaller clinical trials, application of surrogate endpoints and use of adaptive trial designs and Bayesian statistics.”  Likewise, the agency would also be required to “facilitate … expedited and efficient development and review of the device through utilization of postmarket data collection.” Although these are laudable goals, the Act does not impose any specific timelines in which an “expedited review” must be completed or otherwise quantify how much existing review times will be reduced.

Third-Party Inspections of Device Manufacturers

The Act also contains provisions that could allow FDA to conserve its inspectional assets and speed up approval of modified versions of existing devices by allowing for the use of third party inspectors to conduct the necessary establishment inspections.  The theory being that creating a “quick” method to inspect facilities in these circumstances would promote the earlier availability of improved “cures.”

Under the provisions of the Act titled “Medical Device Regulatory Process Improvements,” Congress would require FDA to establish a “third-party quality system assessment” program, where accredited third parties would inspect manufacturers for compliance with the Quality System Regulation (“QSR”) (21 C.F.R. Part 820).  However, use of such third-party inspections would be limited only to QSR inspections necessary as the result of submissions involving “device related changes” and would not be available in other types of establishment inspections.

Changes to Humanitarian Device Exemptions

This section of the Act would double the number of patients that must suffer from a disease in order for FDA to consider it a “rare disease.”    Presently, the HDE pathway is intended to incentivize and encourage the development of devices to treat “rare” diseases or conditions affecting small patient populations when the device manufacturer`s research and development costs would otherwise exceed its market returns.  It does so by significantly reducing the clinical data that would be necessary for the manufacturer to generate to support the efficacy of the device that would otherwise be required by FDA in a traditional marketing application. To qualify for an HDE, the disease or condition must presently affect fewer than 4,000 individuals in the United States per year. The Act seeks to encourage additional development making “cures” more widely available by increasing this number to 8,000 individuals.

Medical Software

In an apparent effort to “modernize” the technology involved in health care, the Act would create a definition of “health software,” which generally would not be regulated unless it:

  • is intended for use to analyze information to provide patient-specific recommended options; or
  • FDA determines that it poses a significant risk to patient safety.

This provision continues to allow FDA some flexibility as to how it may regulate software.  The Act also would require the agency to review existing regulations and guidance regarding software, including the classification of software, standards of verification and validation, review of software, and quality system for software, among others.

Clinical Trials

The Act would also make it easier for sponsors conducting clinical investigations by requiring the Department of Health and Human Services (“HHS”) to harmonize its requirements applicable to clinical investigations with FDA’s own requirements. This supports the Act’s goals by significantly reducing the regulatory burden imposed on sponsors who must presently ensure that their clinical investigations meet the often duplicitous requirements imposed by both HHS and FDA controls.  The Act also would make it easier for sponsors to meet Institutional Review Board (“IRB”) requirements by allowing the use of non-local IRBs to review medical device trials, including Investigational Device Exemptions (“IDE”) and HDEs. Permitting the use of non-local IRBs support the Act’s goal of “quicker cures” by eliminating the “log jam” and delays sometimes associated with the use (and overuse) of local IRBs by giving sponsors additional options that are potentially faster than the traditional ones.

Promotion

Lastly, and without limitation, the Act’s section on “Facilitating Responsible Communication of Scientific and Medical Developments,” provides that FDA “shall, within 18 months, issue draft guidance on facilitating the responsible dissemination of truthful and non-misleading scientific and medical information not included in the approved labeling of drugs and devices.”  This provision appears to be in response to the Coronia Case (U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012)), which holds that representatives of pharmaceutical manufacturers have a right under the First Amendment to make truthful statements regarding their products, even if such statements indirectly promote drugs for uses not approved by FDA.  The Act does not provide further direction on this topic, but Congress is clearly nudging FDA to update its position on off-label promotion which may affect medical device manufacturers.

It may be an uphill battle for Congress to agree on all topics involved in the 308 pages of 21st Century Cures Act.  However, as reported by the House Energy and Commerce Committee Press Releases, the bill appears to have support from industry and consumer groups, which may help bring Congress together.

FDA Provides Another Guidance Concerning FDA’s Use of Foreign Study Data

By Mason Weeda

FDA’s Center for Devices and Radiological Health (“CDRH”) and Center Biologics Evaluation and Research (“CBER”) recently published a new draft guidance entitled “Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States [(“OUS”)] (“Draft Guidance”) (available here). With this Draft Guidance, FDA aims to minimize the possibility for additional or duplicative U.S. studies, to harmonize global clinical trial standards, and to promote public health and innovation.

The Draft Guidance adds to a myriad of policies, statutory and regulatory provisions, and proposed rules on OUS studies, including:

  • FDCA § 569B (or 21 U.S.C. § 360bbb-8) which requires FDA to accept data from clinical investigations conducted OUS, in deciding whether to approve or clear a device. Pursuant to §569B, if FDA finds that such data are inadequate under applicable standards to support clearance or approval of the device, then FDA must provide the sponsor with written notice of the finding and FDA’s rationale.
  • 21 C.F.R. § 814.15 which provides that OUS clinical study data submitted in support of a Premarket Approval Application (“PMA”) and conducted under an Investigational Device Exemption (“IDE”) shall comply with Part 812. If an OUS study in support of a PMA is not conducted under an IDE, FDA will accept studies which have been conducted outside the United States and begun after November 18, 1986, “if the data are valid and the investigator has conducted the studies in conformance with the ‘Declaration of Helsinki’ or the laws and regulations of the country in which the research is conducted, whichever accords greater protection to the human subjects.” If relying on a study that started before November 19, 1986, FDA must be satisfied that “the data are scientifically valid and that the rights, safety, and welfare of human subjects have not been violated.” A PMA based solely on foreign clinical data and otherwise meeting the criteria for approval under this part may be approved if the foreign data are: “applicable to the U.S. population and U.S. medical practice;” “have been performed by clinical investigators of recognized competence;” and “considered valid without the need for an on-site inspection by FDA or… FDA can validate the data through an on-site inspection or other appropriate means.”
  • Proposed Rulemaking. Over two years ago, FDA published a proposed rule on “Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices.” The proposed rule, when finalized, would require that foreign clinical studies in support of PMAs, IDEs, HDEs and 510(k)s be conducted in accordance with good clinical practice (“GCP”).
  • 2001 Guidance. In March 2001, FDA issued guidance on acceptance of foreign clinical studies titled “Guidance for Industry-Acceptance of Foreign Clinical Studies”, which describes the acceptance of foreign clinical studies in support of an application for marketing approval of human drugs, medical devices and biological products. This guidance merely clarifies that FDA incorporated the 1989 Declaration of Helsinki in its regulation governing investigational drug trials conducted in foreign countries and that it was not amending the regulation to incorporate the 2000 amendments to the Declaration.

The Draft Guidance elaborates on FDA’s regulation and provides some insight on what FDA may focus on when evaluating the adequacy of an OUS study. Not surprisingly, FDA makes it clear that sponsors should seek input from FDA prior to initiating an OUS device study to ensure that it will generate adequate and valid scientific data. The Draft Guidance essentially provides three primary considerations related to relying on OUS clinical data:

  • Differences in study populations. To the extent a device has disparate safety effects in different demographic groups, differences in the race, ethnicity, age, gender and sex of a foreign population can affect the applicability of the study to the intended U.S. population. Reporting on the representation of such groups in the device submission allows appropriate sub-group analyses. The foreign population and the intended U.S. patient populations may also differ in the prevalence of clinical factors that can affect risks of an intervention as well as clinical response.
  • Differences in clinical conditions. Differences in OUS clinical conditions versus those in the U.S. can affect the relevance of the data to the intended U.S. population. OUS countries may have different standards of care, clinical facilities, or levels of clinical skill which can cause OUS data to not be generalized to U.S. clinical practice and which can impact the data’s usefulness in supporting the safety and/or effectiveness of the device.
  • Differences in regulatory requirements. When studies conducted OUS are initiated to satisfy the requirements of foreign countries, the studies may not be designed to address the questions necessary to satisfy FDA requirements.

The Draft Guidance provides a number of useful examples that demonstrate the application of the above considerations. Although the proposed rulemaking on “Acceptance of Data from Clinical Studies for Medical Devices” is not yet final, the Draft Guidance concludes by highlighting the importance of GCP. It states that “showing compliance with GCP is one way sponsors of device applications may be able to show that their OUS data comply with applicable FDA requirements.” FDA’s requirements for IDE studies address GCPs through applicable regulations, such as 21 C.F.R. Part 50, 54, 56 and 812. The Draft Guidance also provides that FDA considers the following two standards to be GCP principles that articulate ethical and policy standards for OUS clinical trials:

  • ICH E6, “Good Clinical Practice: Consolidated Guidance,” and
  • ISO 14155 “Clinical Investigation Of Medical Devices For Human Subjects – [GCP]”

FDA is requesting comments on the Draft Guidance before it begins work on the final guidance. The Agency will be accepting comments until July 21, 2015.

Who Regulates the Advertising of Your App?

By Mason Weeda

We have blogged and hosted numerous webinars on FDA regulation of mobile medical apps (see here, here, here, here and here); but if you are an app developer, you should be aware that FDA is not the only agency looking at your app.  The Federal Trade Commission (FTC) may also be watching how you promote your app.  In fact, on February 23, 2015 the FTC announced that it reached settlements with two firms marketing melanoma detection apps.  The agency was unable to reach a settlement with a third developer and intends to pursue a judgment through litigation.  Both apps claimed to provide an “automated analysis of moles and skin lesions for symptoms of melanoma and increase consumers’ chances of detecting melanoma in its early stages.”  In sum, the FTC alleged in its complaints that the mobile app developers lacked adequate evidence to support such claims.

FTC authority coincides with other agencies in many respects, see e.g. here, and here.   And there is nothing really new with the FTC taking action against mobile app developers.  In 2011, the FTC filed complaints against developers of “acne cure” apps that claimed to treat acne through a light emitted from the device if you held it close to your face. The FTC alleged that those claims were unsubstantiated.

The FTC regulates many types of advertising and protects consumers by stopping unfair, deceptive or fraudulent practices in the marketplace. Under the Federal Food Drug and Cosmetic Act, the Food and Drug Administration (FDA) has regulatory authority over the labeling of all medical devices. Labeling includes any “written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article…”   Sections 502(q) and 502(r) of the FD&C Act authorize FDA to regulate the advertising of certain devices, which are known as restricted devices.  Section 502(r) also states that restricted devices are not subject to FTC’s broad authority over advertising under 15 U.S.C. § 52-55.

Dr. Jeffery Shuren, Director of FDA’s Center for Devices and Radiological Health, summarized the FTC/FDA division of authority best: “FDA regulates the advertising of restricted medical devices while the FTC regulates the advertising of non-restricted devices.”   A device becomes a “restricted device” when:

  1. FDA by regulation restricts a device to sale, distribution or use only upon the authorization of a practitioner licensed by law to administer or use such device, or upon other conditions that FDA prescribes in the regulation, if FDA determines that there cannot otherwise be reasonable assurance of the device’s safety and effectiveness.  (Note that prescription devices may or may not be restricted devices).
  1. FDA requires, as a condition of approval of a Class III device, that its sale and distribution be restricted, but only to the extent that the sale and distribution of the device may be restricted by a regulation.
  1. FDA establishes, as part of a performance standard promulgated in accordance with section 514(b) of the FD&C Act, requirements that restrict  the sale and distribution of a device, but only to the extent that the sale and distribution of the device may be restricted by a regulation.

Based on FTC’s description of the melanoma detection apps, it appears that the app developers are likely required to obtain premarket approval (PMA).  FDA’s Mobile Medical Application Guidance provides that the Agency intends to actively regulate mobile apps that “use the mobile platform’s built in features, such as… a camera, to perform medical device functions.”  The melanoma apps use the device platform (i.e. the camera) to collect and review an image for use in providing a diagnosis.   Furthermore, this type of app appears to perform the same medical device functions of an “optical diagnostic device for melanoma detection” which FDA classifies as Class III under product code OYD, which requires a PMA.  In addition, FDA premarket approval letters indicate that “optical diagnostic devices for melanoma detection” are restricted devices pursuant to 21 C.F.R. § 801.109.

It appears that FDA would, upon premarket approval, treat these types of melanoma apps as restricted devices and therefore would have authority to regulate the app’s advertising.  However, it remains that these app developers never submitted a premarket application or received premarket approval from FDA.  Therefore, the Agency was not able to require, as a condition of approval, that their sale and distribution be restricted.  As such, FDA does not have the ability to regulate the advertising of these apps.

The instant FTC complaints and settlements appear relatively minor compared the potential FDA issues involving marketing a product without approval. More importantly, FDA is in no way foreclosed from taking action so we will see if and when FDA acts in the coming months against the app developers.

OFW Law Launches FDA DevicEd Training Initiative

OFW Law is proud to announce the launch of its FDA DevicEd Training Initiative.  The initiative is devoted to providing high quality FDA regulatory training to foreign and domestic medical device companies and the advisors who assist them.  Interactive in-person seminars will be developed and presented by OFW Law attorneys specializing in FDA regulation of medical devices.  These attorneys have a combined total of over 80 years of experience practicing FDA medical device law.

“The scope and complexity of FDA’s regulation of medical devices have only increased in recent years, with the swirl of new or revised statutory provisions and draft and final regulations and guidance documents growing all the time.  The OFW Law FDA DevicEd Training Initiative seeks to help device firms and their advisors navigate the often tricky FDA regulatory landscape in which they must conduct business or provide advice,” says Steve Terman, the head of OFW Law’s Medical Device Practice Group.

Besides communicating the regulatory information that companies and their advisors need, the initiative also is intentionally geared at providing practical insights which can be applied on a daily basis by company employees and firms in the medical device industry.  “While knowing what the law and guidance literally say is important, it doesn’t necessarily help you understand what they truly mean in practice so you can avoid regulatory pitfalls.  This is where the initiative can be of practical assistance,” says Neil O’Flaherty, an OFW Law principal attorney specializing in FDA device regulation.

The initiative will offer seminars for those new to the area of FDA medical device regulation as well as seminars targeting a specific area of FDA device regulation or a new regulatory initiative by FDA’s Center for Devices and Radiological Health.  The initiative also offers the opportunity for device firms and their advisors to work with OFW Law to develop and plan customized seminars to meet their specific needs.  “Not all firms need or want training and education on the same topics.  The OFW Law initiative allows them to design and implement training activities which are tailored to their interests and goals,” according to Evan Phelps, another principal attorney specializing in FDA device matters at OFW Law.

Trained and experienced professionals within and outside FDA are critical to a medical device industry which produces and markets safe and effective products.  OFW Law hopes its FDA DevicEd Training Initiative will be beneficial to industry professionals.

Please contact Neil O’Flaherty for more information about the OFW Law FDA DevicEd Training Initiative.

Please note that OFW Law FDA DevicEd Training Initiative sessions are for general informational purposes only.  They are not intended to and do not constitute legal advice and do not establish an attorney/client relationship.  Please contact an attorney and establish an attorney/client relationship if you need legal advice.

FDA Decides Not to Actively Regulate Medical Device Data Systems, Medical Image Storage Devices, Medical Image Communication Devices and Similar Mobile Medical Apps

By Neil F. O’Flaherty

There is good news for certain sectors of the medical device industry.  FDA has decided not to actively regulate medical device data systems (MDDS), medical image storage devices, medical image communication devices and similar mobile medical applications (apps).  In a pre-published Federal Register notice (available here, which should issue in the Federal Register on Monday), FDA announced the availability of two new guidance documents which are intended to put industry on notice of FDA’s policy change.  The guidance documents are currently available on FDA’s website:

  1. “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices,” (MDDS guidance) available here; and
  1. “Mobile Medical Applications,” available here.

Previously, MDDS and medical image storage and communication devices, and similar mobile medical apps, were regulated by FDA as Class 1, 510(k)-exempt devices.  As such, they were subject to FDA’s medical device labeling, medical device reporting, establishment registration, product listing and Quality System Regulation requirements, among others. The policy change greatly decreases the regulatory burden on these types of devices by not requiring manufacturers and other responsible parties for these types of devices to comply with these requirements.

The MDDS guidance provides that FDA does not intend to enforce compliance with the regulatory requirements that apply to MDDS, medical image storage devices and medical image communication devices.  The September 25, 2013 version of the “Mobile Medical Applications” guidance has been updated to be consistent with the MDDS guidance.  In relevant part, the updated  version deletes the example of Mobile Apps that would be regulated as an MDDS and adds that it intends to use enforcement discretion for apps that are “intended to transfer, store, convert format, and display medical device data in its original format from a medical device (as defined by MDDS regulation 21 CFR 880.6310).”  The guidance also provides an example of when a mobile app meets the definition of an MDDS and gives other examples of where FDA will use enforcement discretion.

Although this is good news for industry, FDA has strict definitions of what it considers an MDDS device, a medical Image storage system and a medical image communication system.  Before taking advantage of the decreased regulatory burden in regulatory and business planning (e.g., commercializing new products, modifying treatment of existing products, etc.), firms need to truly make sure that FDA would view their device as falling into one of these categories.  Wrongly relying on your device falling into one of these categories could translate into an FDA compliance action against your company.

For those firms which have a good basis for claiming their product falls into one of these categories, it is important to document why in a written regulatory rationale.  In this way, if FDA or a third-party ever questions your conclusion, you can use the rationale to convince FDA or the party that you are correct or to at least demonstrate your “good faith” deliberations.

CDRH’s 2015 Weather Forecast Predicts A Storm of Guidance Documents

By Mason Weeda

Earlier this month, FDA’s Center for Devices and Radiological Health issued its FY 2015 Proposed Guidance Development and Focused Retrospective Review of Final Guidance.  CDRH lists 28 guidance documents in total.  The “A-list” includes both draft and final guidances that CDRH intends to publish by January 2016, and the “B-list” includes guidance documents that it intends to publish “as resources permit.”   CDRH is required by the Medical Device User Fee Amendments of 2012 to publish these lists.

The “A-list” includes the following final and draft guidances:

  1. Applying Human Factors & Usability Engineering to Optimize Medical Device Design (Final);
  2. 510(k) Submissions for Medical Devices that Include Antimicrobial Agents  (Final);
  3. Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval (Final);
  4. Expedited Access for Premarket Approval of Medical Devices Intended for Unmet Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (Final);
  5. Framework for Regulatory Oversight of Laboratory Developed Tests (Final);
  6. FDA Notification and Medical Device Reporting for Laboratory Developed Tests (Final);
  7. Coronary Drug Eluting Stents-Nonclinical and Clinical Studies (Final);
  8. Intent to Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification Requirements (Final);
  9. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (Final);
  10. Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections With Small-Bore Connectors Intended for Enteral Applications (Final);
  11. Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile (Final);
  12. Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing Biocompatibility (Final);
  13. General Wellness Products (now published in Draft);
  14. Medical Device Accessories (now published in Draft);
  15. Medical Device Decision Support Software (Draft);
  16. Benefit-Risk Factors to Consider When Reviewing IDE Submissions (Draft);
  17. UDI Direct Marking (Draft);
  18. Informed Consent: Policy for Observational Data Used to Fulfill Device Requirements (Draft);
  19. Adaptive Design for Medical Device Clinical Studies (Draft); and
  20. UDI FAQs (Draft).

The “B-list” includes the following:

  1. Finalizing various existing draft guidance documents;
  2. Medical Device Interoperability (Draft);
  3. Transfer of Ownership of a Premarket Notification: Questions & Answers (Draft);
  4. Direct Access Genetic In Vitro Diagnostics Testing (also known as Direct to Consumer Genetic Testing) (Draft);
  5. Patient Access to Information (Draft);
  6. 3D Printing (Technical) (Draft);
  7. Manufacturing Site Change Supplements (Draft); and
  8. Use of Symbols in Labeling (Draft).

Significantly, CDRH acknowledges that it is not realistic for FDA to publish all guidances on both the “A-list” and the “B-list” by January 2016 and that priorities may change throughout the year.

The Agency also published a third list, containing final guidance documents that were issued in 2005, 1995, and 1985 and are now subject to retrospective review.  CDRH will conduct “a staged review of previously issued final guidances in collaboration with stakeholders,” and it is seeking feedback on whether such guidance documents should be revised.  These guidance documents are:

1985 Final Guidances include:

  1. Medical Laser Delivery System Interlocks (Laser Notice 34) (PDF – 90KB) (1/20/1985);
  2. User Instruction Hazard Warnings (Laser Notice 35) (PDF – 63KB) (2/5/1985);
  3. Policy on Warning Label Required on Sunlamp Products (PDF – 71KB) (6/25/1985);
  4. Low Power Laser Exemption (Laser Notice 36) (PDF – 101KB) (8/23/1985); and
  5. Walk-In Workstations (Laser Notice 37) (PDF – 86KB) (10/21/1985).

1995 Final Guidances include:

  1. Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters (PDF – 896KB) (3/15/1995);
  2. Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians’ Office Laboratory and Home Use (7-13-1995);
  3. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment (7/26/1995);
  4. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes (7/26/1995);
  5. Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles (7/26/1995);
  6. Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Immersion Hydrobaths (7/26/1995);
  7. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables(7/26/1995);
  8. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems (7/26/1995);
  9. Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators (7/26/1995);
  10. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices (7/26/1995);
  11. User Instruction for Medical Products (Laser Notice 44) (PDF – 123KB) (8/11/1995);
  12. Labeling of Laser Products (Laser Notice 45) (PDF – 90KB) (8/15/1995); and
  13. Guidance On The Content Of Premarket Notification [510(k)] Submissions For Protective Restraints (Text Only) (12/1/1995).

2005 Final Guidances include:

  1. Guidance for Industry – Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software (1/14/2005);
  2. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (5/11/2005);
  3. Guidance for Industry and FDA Staff – Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) (7/27/2005);
  4. Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features (8/9/2005);
  5. Guidance for Industry – Review Criteria for Assessment of C Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays (9/22/2005);
  6. Guidance for Industry and FDA Staff: Dental Composite Resin Devices – Premarket Notification [510(k)] Submissions (10/26/2005);
  7. Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 C.F.R. § 1040.30) (11/6/2005);
  8. Guidance for Industry and FDA Staff: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures (11/10/2005); and
  9. Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s (11/17/2005).

FDA has established a docket for comments on any or all of the proposed FY2015 guidance documents or guidance documents subject to CDRH’s focused retrospective review.  FDA invites stakeholders to submit comments on the guidance documents listed, the relative priority of guidance documents for Agency attention and/or suggestions that CDRH revise or withdraw a final guidance document that issued previously in 2005, 1995 or 1985.

2014 And 2015

By Arthur Y. Tsien

As we say goodbye to 2014 and welcome 2015, it’s time for a little backward and forward looking.

Here’s what we saw in the 2014 rear view mirror in our little corner of the Universe devoted to the regulatory aspects of foods, drugs, medical devices, agriculture, and the like.

In January, the Food and Drug Administration (FDA) published its long-awaited, long-overdue draft guidance on the promotion of drug and biologic products in interactive social media.  The draft guidance, formally entitled “Fulfilling Regulatory Requirements for Post-Marketing Submission of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics,” is long on process (how and when to make required submissions to FDA), and short on substance.  Presumably, draft guidances that will address FDA’s views on the substantive content of drug and biologic promotion through social media will follow.

The Agricultural Act of 2014, almost universally known as the 2014 Farm Bill, became law in February.  The Farm Bill is the primary agriculture and food policy tool of the federal government. Enacted every five years, plus or minus (mostly plus), the Farm Bill addresses a broad range of substantive programs administered by the U.S. Department of Agriculture (USDA), including commodity programs, rural development, foreign agriculture and trade, conservation, renewable energy, forestry, nutrition, and other topics.  Unbeknownst to the average American, the Supplemental Nutrition Assistance Program (commonly known as “food stamps”) and other nutrition assistance programs represent by far the biggest expenditure of funds under the Farm Bill.

In March, FDA proposed to update its “Nutrition Facts” nutrition labeling requirements, which have largely been unchanged for over 20 years.  The proposed changes appear to be significant for industry, as FDA estimates the compliance price to be $2 billion.  Even if the proposed changes are not readily noticeable to more casual observers (like me), they are surely of major interest to my colleagues who spend their time looking at the back or side panels of pasta sauce jars or cereal boxes.

In April, President Obama appeared to signal his support for the important role that biotechnology plays in modern agriculture.  Mr. Obama did so in a letter to the granddaughter of Dr. Norman Borlaug, the Nobel laureate who is often recognized as the “Father of the Green Revolution.”

In May, Vermont became the first state to require labeling of genetically engineered foods.  Effective in 2016, Vermont will require the affirmative labeling of foods containing ingredients that are commonly referred to as “genetically modified organisms” or “GMOs.”  The legislation may be vulnerable to a constitutional challenge under the First Amendment.  It, and the prospect of similar legislation in other states, may also serve as the impetus for federal legislation that would preempt some or all state labeling laws related to GMOs.

In June, the U.S. Supreme Court decided Pom Wonderful LLC v. Coca-Cola Co.  The Court held that a company may bring a private lawsuit against a competitor under the Lanham Act to challenge the competitor’s food label, even if the competitor’s label technically complies with FDA requirements.  In essence, the Pom Wonderful decision means that FDA food labeling requirements are a floor, but not a ceiling.  It appears that Pom Wonderful is limited to FDA-regulated products where FDA does not approve or mandate specific labeling, such as food and beverage products.

The Biologics Price Competition and Innovation Act became federal law in 2009, creating a regulatory pathway for FDA approval of “biosimilar” products.  In July, FDA finally accepted the first biosimilar application under that statute.

In August, Grocers Manufacturers Association (GMA) announced an industry initiative that is, in its view, designed to improve the process and transparency for making “generally recognized as safe” (GRAS) determinations for food ingredients.  GMA’s GRAS initiative is intended to respond to criticism about the widespread use of the GRAS process, including FDA’s GRAS notification pilot program, as a mechanism for the review and marketing of new or modified food ingredients.

September marked the 30th anniversary of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act.  Hatch-Waxman is the legislative foundation for the modern generic drug industry in the United States.  Today, generic drugs account for about 80 percent of all prescriptions filled in the U.S.  My personal musings on 30 years of Hatch-Waxman can be found here.

In October, the World Trade Organization ruled in favor of Canada and Mexico, rejecting USDA’s mandatory country-of-origin labeling (COOL) requirements for meat products.  The current U.S. labeling rules, which went into effect in 2013, require meat sold at the retail level to identify the country or countries where the animal was born, raised, and slaughtered.  The USDA COOL requirements were upheld by the D.C. Circuit earlier in 2014.  The U.S. has appealed within WTO; a decision early in 2015 is expected.

In November, OFW Law celebrated its semiseptuagennial anniversary.  Phil Olsson and Rick Frank founded Olsson and Frank in 1979 as a two-lawyer shop.  Fast-forward 3½ decades to 2014.  OFW Law now has nearly 40 lawyers and Policy Advisors, and is one of the few remaining FDA/USDA law and lobbying boutique firms.  Phil’s and Rick’s musings on the past 35 years can be found here.  We look forward to our second 35 years of providing outstanding client service, with creative solutions to difficult problems.

In December, FDA published two companion final rules regarding the labeling of foods sold in chain restaurants and in vending machines.  Covered chain restaurants (and similar chain retail food establishments) will have to declare the caloric content of standard menu items on menus and menu boards and make other nutrition information available on the premises.  Restaurants that are not covered by the final rule may voluntarily register with FDA to receive the protection of federal preemption from inconsistent state and local menu labeling laws.  Foods sold in vending machines will also have to declare caloric content.  Most packaged foods sold in vending machines likely will provide caloric information in the form of a “front-of-pack” label that can be viewed by prospective purchasers.

*          *          *

Enough looking back.  Let’s briefly turn our attention to looking forward, to see what 2015 may have in store for us.  The following come to mind:

  • FDA final rules under the Food Safety Modernization Act (FSMA) on produce safety, preventive controls for human food, preventive controls for animal food, and foreign supplier verification, presumably by the court ordered deadlines in 2015. (Other FSMA final rules have 2016 deadlines.)
  • FDA’s first biosimilar approval. There is no track record here, so no one knows quite what to expect.  For whatever it’s worth, FDA review of biosimilar applications is subject to user fee performance goals, much like user fee performance goals for a variety of other products that require FDA premarket approval.
  • Additional FDA guidance on drug and biologic promotion through social media, hopefully addressing the substance of what FDA considers acceptable and not acceptable.
  • Federal GMO labeling legislation to preempt some or all state requirements in this area.
  • The WTO’s final decision on USDA’s COOL requirements.
  • The extent of cooperation between President Obama and the Republican Congress. Personally, I’m skeptical that they can work together towards less gridlock and more bipartisanship going forward.

*          *          *

Thanks for reading!  Best wishes to one and all for a wonderful 2015, personally and professionally.  May 2015 be better than 2014!

Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part II)

By Evan P. Phelps

In our prior posting, we provided a brief overview of the notification and adverse event reporting requirements that will apply to the vast majority of a subset of in vitro diagnostic devices known as Laboratory Developed Tests (LDTs), most likely in the not so distant future.  These requirements were detailed in the draft guidance documents published on October 3 of this year, outlining the agency’s proposed plan to begin actively regulating firms that produce LDTs.

The draft guidance documents may be found here: Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Oversight of Laboratory Developed Tests (LDTs); and here Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).

This posting provides an overview of the remainder of the regulatory controls outlined in these guidance documents.

PREMARKET REVIEW AND QUALITY SYSTEM REGULATION

FDA will begin applying various levels of additional requirements to LDTs based on the agency’s view of the amount of risk posed by the test. These additional controls will include, among others, premarket review and compliance with manufacturing quality controls found in the Quality System Regulation (QSR).[1] These requirements will apply to both LDTs that are currently in clinical use and to those that a laboratory intends to introduce in the future. The draft guidance indicates that the agency will establish three classes of LDTs and apply varying levels of premarket scrutiny and QSR compliance to each according to the risk they present.

  1. Lowest Level of Scrutiny: No Premarket Review and No QSR Requirements

The lowest level of premarket scrutiny and QSR compliance will be applied to devices considered to be of the lowest risk. These will include “Traditional LDTs.” “LDTs Used for Rare Diseases,” and “LDTs for Unmet Needs.”  While notification and MDR requirements still apply, FDA intends to continue to exercise enforcement discretion regarding premarket review and QSR requirements for LDTs that fit into these categories.

  1. a) Traditional LDTs

Although the use of the term “Traditional LDTs” may appear promising, the agency defines the term in the guidance in a way that is likely to be far narrower than laboratories’ own definition of the term. As a consequence, many laboratories that believe they are offering traditional LDTs may not in fact be doing so under FDA’s definition and will not be eligible for this exemption from the premarket review and QSR requirements. Under FDA’s definition, only those IVDs intended for clinical use that are designed, manufactured, and used within a single laboratory and are of the type of LDTs that were available when FDA first opted to exercise enforcement discretion for LDTs in 1976 are considered to be “Traditional LDTs.”  FDA indicates that it will consider several factors in determining if an LDT meets its definition of a “Traditional LDT.” These factors include:

  • Whether the device meets the definition of LDT (a device designed, manufactured and used by a single laboratory);
  • Whether the LDT is both manufactured and used by a health care facility laboratory (such as one located in a hospital or clinic) for a patient that is being diagnosed and/or treated at that same health care facility or within the facility’s health care system;
  • Whether the LDT is comprised only of components and instruments that are legally marketed for clinical use (e.g., analyte specific reagents, general purpose reagents, and various regulated laboratory instruments); and
  • Whether the LDT is interpreted by qualified laboratory professionals, without the use of automated instrumentation or software for interpretation.

When such criteria are ultimately applied, many laboratories that presently believe that they are offering a “Traditional LDT” may, in fact, learn that they are not and face more significant FDA regulatory burdens.

  1. b) LDTs Used for Rare Diseases

Likewise, the term “LDTs Used for Rare Diseases” is also defined in a way that makes it less inclusive than may initially appear. Rather than basing the definition on the prevalence of a disease, the category is limited to instances where the number of persons that may be tested with the device is fewer than 4,000 per year. If there are more than 4,000 persons a year who would be tested with the LDT, it would not qualify as an “LDT Used for Rare Diseases.” Perhaps a better and more descriptive name than the one chosen by the agency for this category of tests might have been “Rarely Used LDTs.”

  1. c) LDTs for Unmet Needs

Generally, “LDTs for Unmet Needs” are those used to meet urgent health care needs where there is not a comparable FDA-cleared or approved alternative. FDA has published a number of factors it will use to determine if an LDT should be considered one that is “for unmet needs.” These factors include:

  • Whether the device meets the definition of LDT in this guidance (a device designed, manufactured and used by a single laboratory);
  • Whether there is no FDA-cleared or approved IVD available for that specific intended use; and
  • Whether the LDT is both manufactured and used by a health care facility laboratory (such as one located in a hospital or clinic) for a patient that is being diagnosed and/or treated at that same health care facility or within that facility’s health care system.
  1. Highest-Risk LDTs: Highest Level of Scrutiny 

LDT’s presenting the most risk (high-risk) will be considered Class III medical devices and will be subject to the highest level of regulatory control. The premarket review requirements for these LDTs will begin twelve months after the guidance is finalized. FDA considers the highest risk LDTs to include LDTs with the same intended use as a cleared or approved companion diagnostic (i.e., those that provide essential information for the safe and effective use of a corresponding therapeutic product), LDTs with the same intended use as an FDA-approved Class III medical device; and certain LDTs for determining the safety or efficacy of blood or blood products. In most instances, these LDTs generally will require a Premarket Approval Application (PMA) and may remain on the market during the twelve month period and during the pendency of their PMA (provided it is filed within the initial twelve month period following the publication of the finalized guidance). Enforcement of the premarket review requirement for other high-risk LDTs will be phased-in over four years after finalization of the guidance.

  1. Moderate-Risk LDTs: Moderate Level of Scrutiny

Once FDA has addressed the highest-risk Class III LDTs, it will turn to the enforcement of regulatory controls for moderate-risk LDTs which will be considered to be Class II devices by the agency. FDA has yet to identify which types of LDTs will fit into this category. Presumably, the information gathered as laboratories begin complying with the notification requirement will assist the agency in making this determination and the agency has announced that it will issue a guidance to describe what it considers to be Class I, Class II and Class III devices within two years after the guidance is finalized. Beginning five years after the guidance is finalized and continuing over the four subsequent years, FDA intends to begin enforcing the premarket review process for these moderate-risk LDTs and, in most instances, will require premarket notification (510(k) clearance) for their continued marketing.

  1. QSR Compliance for High-Risk and Moderate-Risk LDTs

Compliance with the QSR will be required for both high-risk and moderate-risk LDTs. The QSR sets forth the requirements for the methods used in, and the facilities and controls used for, the design, manufacture, packaging, storage, and installation of medical devices and also includes system requirements in areas of concern to all manufacturers of finished devices.  According to the draft guidance, FDA will continue to exercise its enforcement discretion with respect to QSR compliance for LDT manufacturers of moderate-risk devices until the time that the LDT is the subject of a cleared 510(k). For high-risk LDTs that require a PMA, enforcement discretion will end at the time that the PMA is submitted to the agency for review and approval.

CONCLUSION

The trigger for when FDA will begin enforcing controls is upon the publication of the final versions of these draft guidance documents. Potentially, this could occur as soon as April 2015.  For some laboratories, the shift from operating under FDA’s enforcement discretion to being fully-regulated as a medical device manufacturer is sure to be a significant and difficult challenge. Making such a change will require these laboratories to consider, plan for, and dedicate resources to achieve compliance with FDA requirements. Even for established medical device companies, doing so is no small effort. The key to success for these laboratories will be to begin assessing how FDA’s proposed requirements will apply to their LDTs now, the burdens that they will assume, and to establish a plan to be in compliance before FDA’s enforcement discretion comes to an end.

Until such time, however, FDA is accepting comments regarding these proposed guidances from members of the public. Accordingly, firms have an opportunity to make their voices heard before FDA’s regulatory scheme comes into effect. If you believe that your own organization will be unduly burdened by this proposed regulatory scheme, we would very much encourage you to have your say while there is still a chance that you can make a difference.

[1]               21 C.F.R. Part 820.

GMPs Have Long History That Precedes Application In Medical Products 1

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part V)

By Neil P. Di Spirito

In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years.  Parts I, II, III, and IV focused on Hatch-Waxman, medical privacy laws, FDA’s user fees, and prescription drug traceability.  Today’s blog looks back at changes in drug GMPs over time.

After the Second World War, a group of young veterans developed a method to mix, process, and package bovine intestines in a manner that allowed surgeons to pack organs and stop bleeding.  The product, developed under a $1,500 government grant, proved useful beyond the veterans’ imagination.  From battlefield surgery to bloody noses sustained on college and playground football fields, the specific surface area configuration or form of the product stopped the blood from cuts and contusions.

When the veterans retired in the 1970’s, fading into the collective memories of history, this revolutionary medical advance almost faded with them.  Why?  How could an important medical product simply fade away with the inventors’ lives?  The art of making the product could not be replicated by the scientists and engineers who followed.  The inventors knew how to make the product, but the process had never been reduced to a verifiable and repeatable procedure.

Good Manufacturing Practices (“GMPs”) were developed in other industries prior to the FDA requiring their use in safe production of medical products.  The automotive, aviation, defense, and multiple other manufacturing industries all used GMP’s rigorous procedures with quality systems to assure their products performed as intended, according to specifications, 100% of the time.

To achieve this goal, manufacturing processes are “design-reviewed,” meaning they are formulated with subject matter expert and operational implementation personnel input, to maximize efficiencies in achieving product specification goals.  All materials and equipment are pre-qualified prior to their introduction into the assembly or service process, and point-of-process completion quality systems assure the product meets specifications prior to completion.

Medical products, both drugs and devices, did not initially require GMP production documentation, with the resultant failure to meet expected performance.

The well documented, inadvertent contamination of sulfa drugs with phenobarbital in 1941 (resulting in approximately 300 patient deaths), and failure to totally inactivate polio viruses in one vaccine batch in 1955 (resulting in approximately 60 inoculated patients developing the disease), led to the establishment of Federal GMPs Regulations for drugs (21 CFR Parts 210 and 211) and medical devices (21 CFR 820). In 1978, GMPs developed into the most rigorous of Good Manufacturing Practices.

The meticulous design-reviewed processes are only effective because they are required to be conducted under point-of-process completion quality systems by the entity utilizing the process, to assure the processes are completed as intended. Pre-qualification/validation of raw materials and required services before either are entered into the process, with review of the data at the time is acquired, provide control over the outcome quality.

*Certain parts of this blog were adapted from a Policy Forum article written by Neil DiSpirito and Anton Usala.

Phil Olsson and Rick Frank on 35 Years of Life at OFW

By Philip C. Olsson and Richard L. Frank

Phil: Rick, it’s hard to believe that 35 years have passed since we started this firm as a two-lawyer shop in 1979.

OFW Logo 35th AnniversaryRick: It sure is. I remember working with you at the law firm I joined fresh out of the University of Michigan Law School, and which you had joined several years earlier out of the USDA, where you had been Deputy Assistant Secretary for Marketing and Consumer Services.

In 1979, I was 28, with little experience. You were 40, and a well-known fixture in the agriculture and FDA bar. We decided to take a giant leap of faith and started Olsson and Frank. We persuaded Anita Harris to join us as our all-purpose support staff.

Phil: Our initial clients were food and agriculture companies and trade associations, including American Feed Manufacturers Association [now American Feed Industry Association], National Turkey Federation, Pacific Coast Meat Association [now North American Meat Association], The Quaker Oats Company, and Pueblo International.

Rick: Amazingly, many of those clients from 35 years ago are all still our clients today. We appreciate their loyalty and support over the years.

Phil: Today, food and agriculture are still a major part of our practice. But our practice has evolved and grown to include a wide range of industries regulated by USDA and FDA. We are still primarily a regulatory and counseling practice, with litigation capability.

Rick: We have had some notable successes from the outset.

Phil: Our first big challenge involved the National Turkey Federation, defending recently adopted USDA labeling regulations for “turkey ham,” which was allowed as a product name as long as it was qualified by the phrase “cured turkey thigh meat.” Two meat industry associations challenged that regulation. Before the District Court in Norfolk, we had a particularly unsympathetic judge, who began his opinion with an excerpt from Lewis Carroll about “when pigs have wings.” Fortunately for our client, the Fourth Circuit agreed with us and upheld USDA’s regulation. That win showed that our small firm was a feisty advocate. No one has ever doubted that Rick can be feisty, but that victory showed that our small firm had been inoculated with his feisty DNA.

Rick: The “turkey ham” case was important for the food industry, because it allowed product innovation to proceed without artificial constraints on product names. Along the same vein, for years we successfully fought off efforts by the dairy industry to demonize “imitation cheese” used as an ingredient in a wide variety of refrigerated and frozen meat-topped pizzas regulated by USDA.

Two other victories come to mind. We successfully got “Fresh Choice” orange juice and “Fresh Italian” pasta sauce off the market. Those products, which were made from previously processed, heat-treated concentrates, were anything but “fresh.” We also helped get approvals for lean, finely textured beef, a highly innovative, nutritious, and lower cost meat component widely used in ground beef and related products. (Note: Unfortunately, a disgruntled USDA employee, a “mommy blog,” and a national TV network disparaged this wholesome product as “pink slime” several years ago.)

Phil: One of my favorite clients was an egg distributor. On a trip with him to Cuba, we got to spend about five hours with just Fidel Castro, Castro’s trade director, and Castro’s interpreter. We heard Castro talk at length about improvements in Cuban literacy and life expectancy that had taken place since he took power in 1958. I have a treasured photo of me with El Presidente in my office.

Rick: It’s been a great 35 years, with lots of interesting matters. From the beginning, we always worked hard, tried to develop “creative solutions to difficult problems,” and fought to win our cases. We charged fairly for our services and worked in a very collegial environment. We still follow those guiding principles, which have served us well.

Phil: Indeed, those principles have worked well for us, as we have grown and prospered over the years.

Rick: In our early days, I was usually the youngest person in the room; Phil, you were the tallest. Today, I am often the oldest person in the room, but you are still the tallest. Some things change; some things don’t.

Thirty-five years have sped by. You, Anita, and I are all grandparents. The firm has grown, slowly but steadily, from two lawyers to almost 40 lawyers and Policy Advisors today.

Phil: In the beginning, you and I quickly realized we needed someone with more FDA expertise. In 1981, we were extremely fortunate to be joined by David Weeda, who had worked in FDA’s Office of Chief Counsel. David’s practice focused on drugs and biologics.

Next, Dennis Johnson joined us in 1982 after completing a Food and Drug Law Institute internship with FDA’s Office of Chief Counsel. He rapidly developed a practice representing packing and processing firms on their individual issues with USDA’s Food Safety and Inspection Service. Despite government warnings on each cigarette package, DJ has never been able to give up his Lucky Strikes, and he developed close friendships with a number of FSIS decisionmakers while sharing their smoking breaks.

Rick: David was responsible for recruiting his former FDA Office of Chief Counsel colleagues, Arthur Tsien and Steve Terman, to join us. Both have fit in very nicely. Today, Arthur is the head of our drug practice and our animal food and animal drug practice, while Steve heads our medical device practice.

Phil: Marshall Matz and I have known each other since the days when he was counsel for Senate George McGovern’s Hunger Subcommittee and I was working on hunger issues for the Nixon Administration at USDA. Marshall joined us in 1992 and has built a world-class policy and lobbying practice.

Rick: Marshall’s practice fit in neatly with the non-lawyer Senior Policy Advisors that have joined us over the years. The first was John Block, President Reagan’s first Secretary of Agriculture and the youngest member of the Reagan Cabinet. Jack is to-this-day a corn and hog producer and before coming to Washington he had been the Illinois Secretary of Agriculture. We also have former Congressman Charles Stenholm. Charlie had been the leader of the Blue Dog Coalition in the House, a group of moderate Democrats who worked to build bipartisan consensus.

We are also pleased to have Dr. Barbara Masters, a veterinarian and a former (non‑smoking) Administrator of FSIS. Barb began working for USDA straight out of vet school and burst through several (age and gender) glass ceilings to become FSIS Administrator before she was 40.

Phil: And we’re privileged to have had many other talented individuals join us over the years.

Rick: Absolutely. We have the O’Flaherty Brothers from Chicago. Michael heads our food practice. Neil is a stalwart in our medical device practice. David Durkin and Tish Pahl are an important part of our drug practice. Brett Schwemer and Jolyda Swaim are part of our meat and poultry practice, while Evan Phelps works on medical device matters. Jon Weinrieb is our resident maven on medical privacy. We added Gary Baise and his team to work on agriculture-related litigation. Bob Hahn works on food matters. There are others, of course.

Phil: David Weeda is an “almost founder” of this firm. Unfortunately, David succumbed to lymphoma at an all-too-early age in 2001. We are now fortunate to have a next generation Weeda, David’s son Mason, as one of our up-and-coming associates.

Just as we were in the process of moving our offices to The Watergate in 2011, Marshall persuaded his old friend and mentor Senator McGovern to join us as a Senior Policy Advisor. Marshall liked to point out that we had brought Senator McGovern back to The Watergate. The Senator remained one of us until he passed away.

Rick: In 35 years, much has changed, but much remains the same. We are still a relatively small, quirky boutique, specializing in food, agriculture, drugs, devices, and related litigation.

Phil: Along the way, we’ve done many different kinds of things. Rick has been heavily involved in community activities as the founder of the Lawyers Have Heart 10K foot race and fundraiser, which has raised millions of dollars for the American Heart Association during the 25 years of its existence. He has also worked closely with a number of consumer organizations, building credibility to obtain consumer support for some of our client causes.

In the 35 years since 1979, our country has been led by six presidents. We have seen many of the national and international mega-law firms stumble and disappear. From the beginning, our firm has been fortunate to have had Rick’s prudent management skills, which I believe he absorbed while watching his parents and grandparents run a small family business. Thirty-five years at OFW has been a great ride with a great group of people, both those within the firm and those on the outside, the clients who have made it all possible.

Rick: It sure has been a great ride and it’s not over. We are in the process of grooming tomorrow’s leaders. I still love my view of the Potomac from my office in the Watergate Building – the planes and helicopters and boats coming and going. Our cases were and are challenging and interesting. Washington is a wonderful place to work and raise a family.

On to the future!