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.

How Much Rain Has Fallen In Texas?

By Charles W. Stenholm

In the month of May, Texas received over 35 trillion gallons of rain.  See the graphic, below, to put that into perspective.

Many prayers were answered as we went from extreme drought to an overabundance of rainfall.  Truly a blessing!  It is much more difficult to do without water than deal with having too much.  Just wish the loss of life and property could be avoided.  We did, however, see many of the benefits of investing in flood control pay some dividends.

TX Rainfall

Click graphic to enlarge.

Why Adesina’s Election is Important for Agriculture

By Marshall L. Matz, as published in Agri-Pulse

In a surprise upset, Dr. Akinwumi (Akin) Adesina was elected to be the next President of the African Development Bank (ADB), defeating seven rivals in six rounds of voting.  Adesina holds a PhD in agriculture economics from Purdue and has been serving as the Minister of Agriculture in Nigeria since 2011.

Adesina is the first agriculture economist to become President of the ADB.  He is a dynamic leader with a passion for rural development (and bow-ties).  According to The Guardian, under his leadership in Nigeria, “food production increased by 22 million tons and food imports dropped more than a third,” creating some three million jobs.

The ADB is one of Africa’s largest lending institutions, making Adesina one of the continent’s most prominent financial leaders. Africa now has six of the world’s fastest growing economies and, as agriculture becomes more efficient, the economy will grow even faster. Over 65% of the population farms or is engaged in agriculture. However, yields are so low that feeding a family takes 70% the its disposable income and Africa must spend $35 billion to import food.

Adesina’s goal is to make Africa globally competitive.  Upon his election he said, “A big thing for us in Africa is to create an inclusive model with jobs for Africa’s youth, jobs for Africa’s women, revive Africa’s rural areas and have regional integration for shared prosperity.” He also noted that “there is no developing Africa without empowering women.”

The challenge Adesina faces will not be easy.  Political stability varies widely in Africa’s 54 sovereign nations as does infrastructure, education and health care, but things are clearly changing and changing fast.

Adesina will have some important allies to work with in his new capacity:

  • The Chairperson of the African Union, Dr. Nikosazana Diamini- Zuma, is asking all African countries to invest at least 10% of their respective national budgets in agriculture.  The program, called the Comprehensive Africa Agriculture Development Program (CAADP), is having an impact.
  • Dr. Agnes Kalibata, the new President of the Alliance for a Green Revolution in Africa (AGRA) holds a doctorate from the University of Massachusetts in entomology.  She was the Minister of Agriculture in Rwanda and was widely considered to be one of the most successful agriculture ministers in sub-Saharan Africa.  At AGRA, Dr. Kalibata is working with African experts in some 18 counties to fulfill the vision of food self-sufficiency.
  • Strive Masiyiwa, the Chairman and CEO of Econet Wireless, is the “Bill Gates of Africa” according to Forbes, but is focusing the attention of Africa’s private sector on agriculture through his work with AGRA and Grow Africa.
  • Former Secretary General Kofi Annan, Chairman Emeritus of AGRA,  says “it’s time to turn hoes into tractors,” and is committed to helping through the Kofi Annan Foundation.

These African leaders are working closely with the G-7, G-20 and key leaders closer to home here in the United States. Those leaders include: Gayle Smith, who is an Assistant to President Barack Obama and Senior Director at the National Security Council. In that capacity, Smith is responsible for global development and helped to craft the Camp David Accords creating a commitment to African agriculture.

During the Clinton Administration, Smith was Senior Director for African Affairs at the National Security Council.  President Obama has now nominated Smith to be the next Director of the Agency for International Development (AID). Smith is well-qualified for the AID position and hopefully, the U.S. Senate will quickly confirm her nomination.

While there are many others committed to growing Africa out of poverty, in the U.S., special recognition must also go to Pamela Anderson at the Bill and Melinda Gates Foundation and Judith Rodin at the Rockefeller Foundation.

All of these people are coming together for Africa. The Renaissance is underway and the election of Dr. Akin Adesina is the latest very important development. According to Dr. Adesina, “The kind of Africa we need today is an Africa where the young people want to stay, not a place they want to move away from…and an Africa we can all be proud to call home.”

As Adesina knows, agriculture development must be at the center of the African Renaissance. As modern seeds and inputs, along with education, reache the stallholder farmers, production and profitability will improve. That will drive the African economy to new levels of success and, in the process, move Africa and the world toward food security.

The African Development Bank made an inspired choice.

Marshall Matz specializes in agriculture and food security at OFW Law in Washington, D.C.  He also serves as the DC representative for the Alliance for a Green Revolution in Africa.

Former Consumer Products Safety Commissioner Nancy Nord Joins OFW Law

We are pleased to announce that Nancy Nord, former Acting Chair of the United States Consumer Product Safety Commission, has joined OFW Law as Of Counsel.  Nord is a nationally recognized expert on safety regulation and corporate compliance with a wealth of experience in both the public and private sectors.

Please click the announcement, below, to enlarge it.

Nancy Nord Announcement

John Block: GMOs Under Assault

By John R. Block

We can’t seem to silence or satisfy the loud scream of opposition to GE crops. The reason probably is that up until now we have ignored them. It’s time to stand up and set the record straight.

GE food is safe and even beneficial according to 88% of scientists. We have conducted more than 1,000 studies. We have been eating GE food for more than 20 years – no one has gotten sick.

The fact is that for thousands of years, farmers have been improving crops through selective breeding. That process alters genes. We have found that in the laboratory we can do it faster.

Never mind the facts, the critics are beating the drums. Three states have passed labeling laws. Vermont is in the lead as they begin to implement their law. It sounds simple. Just label the food if it has GMO products in the food.

It’s not that simple. Vermont has a long list of exemptions. Animal products are exempt – beef, pork, chicken, dairy. But keep in mind the animals were fed GMO corn and soybean meal.

Trying to get out ahead of everyone, Chipotle recently announced that it has gone GMO free. But it’s not really free. The soft drinks are made with GMO corn sweetener. The burritos have GMO corn-fed beef, pork, chicken, and GMO sour cream.

The U.S. Congress is considering as many as 30 bills to deal with the GMO debate. You may wonder where all of this noise is coming from. Yes, there are individuals that sincerely are concerned about GMO safety. However, the organic companies (some of them are huge) are helping to push the false argument about risk. If they succeed, they can sell more product and make more money.

This debate is not over. You will soon read about the next step in plant technology – gene editing. Gene editing is a more precise way to alter plant traits.

The leading critics of GMOs are totally inconsistent. First, they support the science on global warming, but ignore the science on GMOs. Next, they pretend to care about the poor, but genetic engineering helps the poor by keeping the cost of food down. The world will not produce enough food without new technology. Finally, if they want to reduce the use of chemicals and energy, GE also does that.

Stay tuned.

John Block was Secretary of the U.S. Department of Agriculture from 1981-1985, where he played a key role in the development of the 1985 Farm Bill.

John Block: “COOL” Isn’t Cool

By John R. Block

As a farmer, we understand that if you have something that doesn’t work, you fix it. It will just cost you money if you ignore the problem. Somehow, the federal government doesn’t seem to understand that common sense fact.

The Country of Origin Labeling (COOL) law was first passed in 2002. Canada and Mexico have been challenging the law now for 13 years. The World Trade Organization (WTO) just this week ruled it to be a violation of U.S. international trade obligations. We are a member of the WTO and therefore should live within the rules. That is our obligation, and we expect other countries to do the same.

This week, for the third time, the WTO ruled against us. That ruling gives Canada and Mexico the legal right to retaliate. Canada already has a list of proposed restrictions, which will result in a dramatic cut in our exports to Canada and Mexico. That is serious. Canada and Mexico are our number 1 and 2 export markets. Besides, they are our closest neighbors.

Senator Pat Roberts (KS) had this to say: “If Congress doesn’t act swiftly, retaliation will wreak havoc on the U.S. economy.” I think we should be aware that if we don’t fix this law, it will cost us millions of dollars in ag exports as well as other exports.

The law today requires that meat from a calf born in Canada and shipped to the U.S. bare a label that reads “Born in Canada, raised and slaughtered in U.S.”  Just imagine the cost and confusion that can cause.  What about the Montana farmer who imports Canadian calves and mixes his own U.S. calves with the Canadian calves?  By law, he would have to keep track of them and market them separately. The U.S. processing plant would then have to process them separately. That would be the only way to ensure the Canadian label was on the Canadian steak.

Consumers say they have the right to know where that animal has been. Why? It isn’t worth the hassle. USDA just released new study results that point out the COOL labeling policy costs consumers nearly 8 billion dollars over 10 years.

We don’t need to try and change COOL. We’ve tried that before. COOL isn’t cool. Just get rid of it.

John Block was Secretary of the U.S. Department of Agriculture from 1981-1985, where he played a key role in the development of the 1985 Farm Bill.

FDA Releases Draft Guidance on Compounding Animal Drugs

By Tish Eggleston Pahl

Yesterday, FDA released a Draft Guidance for Industry on Compounding Animal Drugs from Bulk Drug Substances (Draft Guidance).  The Federal Register notice accompanying the Draft Guidance can be found here.  The agency also withdrew its previous Compliance Policy Guide (CPG) 608.400, Compounding of Drugs for Use in Animals.

Though FDA has been actively implementing Title I of the Drug Quality and Security Act (DQSA) and exercising its new, clearer authority over outsourcing facilities and compounding pharmacies, the new §503B and amended §503A of the FD&C Act do not apply to the compounding of animal drugs. Arising from FDA’s recent, vigorous oversight of compounding pharmacies and outsourcing facilities, the Draft Guidance reflects the agency’s current, and more sophisticated, thinking about compounding.

The Draft Guidance describes the conditions under which FDA does not intend to initiate enforcement action against State-licensed pharmacies, licensed veterinarians, and facilities registered as outsourcing facilities under §503B of the FD&C Act that compound animal drugs from bulk drug substances. Outsourcing facilities are new entities created under the DQSA that, if they follow cGMPs and other requirements, are permitted to compound sterile injectable drugs for humans without FDA pre-approving an application under §505 and without the “adequate directions for use” required by §502(f)(1).  The Draft Guidance sets out pre-conditions for the exercise of enforcement discretion for each type of entity – State-licensed pharmacies, licensed veterinarians, and outsourcing facilities.  Unlike pharmacies and veterinarians, outsourcing facilities will only be permitted to compound from bulk substances identified in the to-be-developed Appendix A.

FDA separately seeks comments on the list of acceptable bulk substances to add to the Appendix A list.  The agency also asks for comments on various other issues, including:

  • The significance of drug shortages to animal drug compounding;
  • The appropriate standards for compounding by licensed veterinarians;
  • Possible limitations on total drugs to be compounded and whether they may be transferred or sold to others; and
  • Whether the agency needs to address repackaging of animal drugs, as it did for human drugs.

For compounders of animal drugs, these are significant documents that warrant close inspection.  FDA will be accepting comments for 90 days.

Mike’s Legacy

By Marshall L. Matz, as published in Agri-Pulse

Michael B. Jandreau, the visionary leader of the Lower Brule Sioux Tribe in South Dakota for almost 40 years, passed away last month at the age of 71.  Known to all as “Mike” he believed that Indian Tribes had to establish a private sector economy on the Reservations if they were to participate in the American dream. The historic treaties of the 1800’s between Tribes and the United States, while still very important, were not enough to prepare Indian people for the 21st century.  For rural Tribes, that means a focus on agriculture.

Jandreau testified before Congress and the South Dakota Legislature many times in support of Tribal sovereignty but he also believed that the treaties were not a business plan. The Tribes needed to develop a private sector economy to benefit all Tribal members.   In 2004, he made history as a Tribal Chairman by telling the Senate Committee on Indian Affairs: “Sovereignty is the key to tribal existence.  But, in the long run, for sovereignty to survive, there must be economic sovereignty as well.  We must develop a private sector economy.”

Jandreau again emphasized the importance of the private sector when he addressed the Senate Committee on Indian Affairs a few years later: “It is painful to read The World is Flat and to read that the United States is outsourcing jobs to China and India when many Indian Reservations have an unemployment rate over 80% and a third world standard of living.”

Tribes located in the Missouri River Valley may face the most difficult challenge of all Reservations given their remote locations.  The unemployment rates on rural Reservations, along with social indicators like infant mortality, diabetes, and suicide rates, are closer to those of the third world than those of the United States.  Tribal members face the Hobson’s choice of leaving their families and culture or staying on the Reservation and a life with less potential than other Americans.  Only a private sector economy can solve these problems and agriculture has the best potential in these rural areas.

USDA photo by Ken Hammond.

USDA photo by Ken Hammond.

Mike foresaw the reservation’s agriculture potential not only in growing larger volumes of agricultural commodities on Tribal and Reservation lands, but also in adding value to those commodities on the Reservation itself.  Processing the commodities created good jobs for Tribal members and pride in what was produced in the name of the Tribe.

Under Jandreau’s leadership, Lower Brule established a successful Farm Corporation and one of the most diverse and innovative economies of any Reservation in the Nation. The Lower Brule Farm Corporation grows edible beans, has a commercial buffalo herd and is the largest producer of popcorn in the country.  The farm has expanded to some 40,000 acres with 10,000 acres under irrigation. They sell popcorn nationwide to the major brands and also market under their own brand name “Lakota Foods.”

As important as agriculture is to Lower Brule, Mike also understood that agriculture alone could not raise the standard of living for Tribal members to parity with surrounding non-Indian communities. He shrewdly recognized that the Indian Reorganization Act of 1934 empowered tribes to team up with the private sector to develop off-reservation businesses that could supplement on-reservation services.  It took a full decade and trips to the Supreme Court to bring land into trust near the Reservation on Interstate 90 in South Dakota that can be developed into Tribal businesses.

Jandreau successfully urged the Congress to enact the Lower Brule Infrastructure Development Trust Fund Act, the Wildlife Habitat Restoration Act and the Wakpa Sica Reconciliation Place, among other pieces of legislation.  Wakpa Sica seeks to help all Tribes of the Great Sioux Nation by providing support for Tribal Courts in order to attract investment to the Reservations.

His unfulfilled dream was an Indian Agriculture Act (IAA). Upon his motion, the National Congress of American Indians passed a resolution urging the United States Congress to “make the Indian Agriculture Act a title in the 2012 Farm Bill.”

While pieces of an IAA were included in the last Farm Bill, Jandreau always looked to the future. Rural, agriculture-based Tribes need extension services, loan guarantees, irrigation, infrastructure, and better internet, among other things, to underpin a farm economy.  South Dakota State University and Mike were working together to improve extension services on all South Dakota Reservations.

Agriculture Secretary Tom Vilsack has been very responsive to Tribes, but to solve a challenge of this magnitude, it will take a Presidential initiative that brings together all Departments of Government.  The White House Rural Council has established a focus on Tribes for this exact reason.

Jandreau proposed paying for increased services by using a portion of the revenue from the sale of electricity generated by the dams along the Missouri.  His thinking was that the water belonged to Indians (under the Winters Doctrine), the dams flooded Tribal land and, therefore, the revenue should be shared with the Tribes.  The Western Area Power Administration, WAPA, earns a billion dollars a year from the sale of electricity.  The revenue is not shared with the Tribes and, in fact, the Tribes have to pay for electricity.

Mike received many awards and commendations over his life but his true legacy lies not in the past but in his vision for the future: A comprehensive Indian Agriculture Act, completing the Wakpa Sica Reconciliation Place, attracting private capital to the Reservations, and distributing the Keepseagle vs. USDA litigation funds to the farmers who were damaged.  As Mike noted in closing his testimony to Congress, “The Reservations are a part of the United States, but we are not a part of the U.S. economy.”

Marshall Matz started his career with South Dakota Legal Services on the Crow Creek Reservation before moving to the Senate Committee on Agriculture.  He currently specializes in agriculture at OFW Law in Washington, D.C.

May 19 Webinar on the Drug Supply Chain Security Act

Tish Eggleston Pahl will be speaking on May 19 at a webinar on dispenser obligations under the Drug Supply Chain Security Act (DSCSA).  The webinar is sponsored by the Healthcare Distribution Management Association (HDMA).  This “DSCSA Overview for Dispensers” continues HDMA’s education and outreach on the pharmacy and hospital–related implementation requirements under the DSCSA.  Particular focus will be on the data requirements for dispensers that go into effect on July 1 and also will address many of the questions that HDMA received during its previous April 21 webinar for dispensers.

Topics will include:

  • The loan or sale of medication from one dispenser to another;
  • The definition of “dispenser” and whether hospital and clinic pharmacies qualify;
  • Questions pertaining to suspect and illegitimate products;
  • Data that must be provided with the product, including questions about lot number and data pertaining to returned products;
  • Exempt products and transactions;
  • Questions around authorized trading partners and more.

The webinar is free.  More information about the webinar and how to sign up is available here.

John Block: Raisins

By John R. Block

The U.S. Supreme Court decides a lot of very serious, high-profile cases – gay marriage for example. However, recently, they heard one about raisins. Yes – raisins.

The Raisin Program dates back to the Great Depression of the 1930s. President Roosevelt cut the production of many farm products to reduce surplus and raise farm prices. My grandfather told me that they even killed baby pigs.

In the recent case, almost 80 years later, the government came to get raisins from the Marvin Horne farm in California. He said “no.” They fined him $700,000 and now they are in court. Under the Raisin Program, the annual crop is reviewed by the Raisin Administrative Committee. Then, the Department of Agriculture decides what percent of the farmer’s crop must be handed over to the government. The government can then give raisins to the School Lunch Program or maybe sell them and give the farmer some of the money.

Justice Breyer argued, “The government was not taking the raisins and giving the farmer nothing. He benefited from higher prices.”

Conservative Justices consider the Raisin Program to be an unconstitutional taking of private property without just compensation. Justice Roberts complained, “You come up with the truck and you take their raisins – probably in the dark of night.”

Justice Kagan pointed out, “We think this is a ridiculous program, but the ridiculousness or sensibleness of a program is not for us to decide.”

The court verdict should be announced by July. Now, to set the record straight – we have had government production control programs for years and years. Most of those control programs have been eliminated, but not all. A few years ago, the “UglyRipe® tomato,” grown in Florida, was not allowed to be sold out of that state. OFW Law was asked by a company growing the UglyRipe® tomato to help them. The Tomato Marketing Order that they were under would not allow them to sell the UglyRipe® tomato in any other state – just Florida. I did work with the USDA and eventually they lifted the Order. I saw UglyRipe® tomatoes in the supermarket here in Virginia last week.

I am not a big supporter of these government control programs. Maybe they served a purpose in the Great Depression. That’s not today. We have moved beyond that. Let the free market work.

What would your reaction be if the government came and took some of your corn after you harvested it?

John Block was Secretary of the U.S. Department of Agriculture from 1981-1985, where he played a key role in the development of the 1985 Farm Bill.