U.S. Senator Al Franken (D-Minn.) introduced the bipartisan Patient Access to Medical Innovation Act (S. 1865) to get innovative medical devices to market more quickly and safely. Senators Lamar Alexander (R-Tenn.), Kay Hagan (D-NC) and John Kerry (D-Mass.) are the lead cosponsors of Sen. Franken’s legislation.
More importantly, Senator Franken’s bill proposes changes to Food and Drug Cosmetics Act (FDC Act) Section 712, Conflicts of Interest.
As explained by the FDA Law Blog, currently, section 712 limits the number of conflict-of-interest waivers that FDA may provide to experts that it would like to serve on its advisory committee. The result of this restriction has been that FDA is often unable to obtain industry’s most qualified experts to serve. As we have noted over the past several months, reports have estimated that almost one third of seats on FDA advisory committees in 2010 were vacant.
The language in Senator Franken’s bill would require FDA to “ensure that each [waiver] considers the scope and magnitude of the financial interest at issue with the public health need for the expertise of the member on the advisory committee.” This is intended to allow FDA to access a broader range of experts who would be unable to serve under the current legislation, and balance the potential conflict-of-interest against the need for participation by experts in a particular field. Such expert consultation can play a critical role in bringing products to market.
Essentially, the bill would require FDA to use the same conflict of interest policy as the National Institutes of Health (NIH) and all other federal agencies.
The Boston Globe noted that, “the FDA requires up to 18 advisory panels be summoned to evaluate new medical technologies when the agencies lacks their own experts to do so. But stringent restrictions on panel members now often prevent the best experts from reviewing specific devices or technologies, according to Kerry’s staff, and thus significantly slow the approval process.”
Franken’s bill joins several other bipartisan FDA bills recently introduced to change the FDA conflict of interest rules, including The “Medical Device Regulatory Improvement Act (S. 1700), introduced by Senators Amy Klobuchar (D-MN), Richard Burr (R-NC), and Michael Bennet (D-CO). S. 1700 would restore the appropriate balance to conflicts of interest requirements by requiring the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government, under the Federal Advisory Committee Act.
Additionally, Congressman Michael Burgess, M.D., (R-TX) introduced The Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 (H.R. 3206) to help FDA obtain expert advice on advisory committees by eliminating limits on the number of conflict of interest waivers FDA can issue. The bill would instruct the Department of Health and Human Services (HHS) Secretary, when considering potential conflicts of interest, to consider the totality of the type, nature and magnitude of any financial interest, without focusing on any one factor over another.
Senator Franken (D-MN) Bill
As noted by the StarTribune, Franken’s bill would make it easier for some medical experts to serve on FDA panels that offer recommendations on medical devices for rare diseases. Franken said he believes the current structure of the panels is “subjected to overly stringent rules” that make it difficult for them to use outside experts because of perceived conflicts of interest with the private sector.
Franken said his proposal would have the panels comply with other conflict-of-interest rules that the National Institutes of Health uses. “As a nation, we need to do more to support this industry so it can continue to expand and provide high-quality jobs — not to mention life-saving technologies — to our markets and our hospitals,” Franken said in a statement.
“After speaking with countless patients, doctors, and members of the medical device industry in Minnesota, I’ve learned that certain barriers in the regulatory process are making it harder to get patients the medical devices they need,” said Sen. Franken in a press release announcing the bill. “My legislation would remove unnecessary barriers so that these critical medical devices get to the patients that need them as quickly and safely as possible.”
Patient Access to Medical Innovation Act would:
- Promote the development of devices to treat patients with rare diseases;
- Help improve the federal Food and Drug Administration’s (FDA) approval process for medical devices by allowing the agency to more easily consult with experts;
- Lift the current profit cap on “humanitarian use devices”– devices that treat rare conditions– that go through a special approval process. Eliminating this red tape will support the development of treatments for people with rare conditions.
Last week, Franken visited Medtronic in Mounds View, MN, and met with several hundred company officials and employees to discuss his new legislation. While there he also met with doctors and patients who may be helped by his legislation. They all agreed on the need for these reforms during his visit. Franken also recently participated in a hearing on medical devices in the Senate health committee, of which he is a member.
A summary of Franken’s bill on FDA Law Blog noted that it will accomplish two main goals: first, to allow manufacturers of products granted a humanitarian device exemption (“HDE”) to profit from development of devices used in both adult and pediatric populations and, second, to ease conflict of interest restrictions on FDA advisory committee members.
Manufacturers may obtain an exemption from the effectiveness requirements for a device if
- the device is “designed to treat or diagnose a disease or conditions that affects fewer than 4,000 individuals in the United States,”
- the device would not be available to a person with the disease or condition unless FDA granted the exemption, and there is no comparable device available to treat or diagnose the condition, and
- “the device will not expose patients to an unreasonable or significant risk of illness or injury and the probable benefit to health from the use of the device outweighs the risk of injury or illness from its use.” FDC Act § 520(m)(2).
Senator Franken’s bill retains these requirements for obtaining an HDE. What it changes is the manufacturer’s ability to profit from sale of an HDE device. Currently, the law prohibits a manufacturer from selling the device “for an amount that exceeds the costs of research and development, fabrication, and distribution of the device,” unless the device “is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs.” FDC Act §§ 520(m)(3), 520(m)(6)(A)(i)(I). Senator Franken’s proposal would allow manufacturers to profit from the sale of any device granted an HDE, regardless of the intended patient population.
Senator Franken’s bill also includes language that would make the legislation retroactive. This means that manufacturers who currently market a product under an HDE, and who are unable to profit from the sale of such device, will be able to profit after the legislation is enacted, even if they obtained the HDE prior to its enactment.
“This summer when FDA Commissioner Hamburg joined me in Boston to hear from Massachusetts industry leaders, we talked about building a new relationship where our innovators work with federal regulators to get the best medical breakthroughs to the patients that need them most,” Kerry said in a statement.
“This legislation strengthens the approval process while cutting the red tape that keeps these critical devices from the hospitals, doctors, and nurses who can use them to save lives. Massachusetts has long been at the heart of these technological innovations, and I’ll continue to do all I can here in the Senate to protect and encourage that innovation.”
Conclusion
With greater momentum to change conflict of interest rules at FDA, and more bipartisan support from Congress, it is likely that congressional officials will push for these bills to be included in the Prescription Drug User Fee Act V negotiations, which will likely be finalized sometime this spring or early summer. Moreover, now that several bills have appeared addressing the conflict of interest policy issue, we could see a congressional hearing in the next few months to address these concerns head on.