Bipartisan 'must-pass' bill approved unanimously; amendments on generic drugs, children's cancer drugs, off-label information are withdrawn

The House Energy and Commerce Committee on June 7, 2017, voted unanimously to approve a five-year reauthorization of the Food and Drug Administration's user fee regime (HR 2430). The vote on the bill, titled the Food and Drug Administration Reauthorization Act (FDARA), was 54-0.

In addition to a manager's amendment from Chairman Greg Walden (R-OR), the Committee approved amendments: on medical imaging device applications; requiring a report on the quality and safety of serviced devices; requiring FDA to classify a medical device based on its own risk when used as intended; and requiring an FDA pilot program providing information on the safety and effectiveness of certain devices. A handful of amendments were also defeated or withdrawn (see below).

Materials related to the markup are posted here. The text of the manager's amendment offered by Chairman Walden is attached to this Alert.

HR 2430 updates and reauthorizes the FDA's user fee programs for prescription drugs (Title I), medical devices (Title II), generic drugs (Title III) and biosimilar biological products (Title IV). Title V of the bill reauthorizes elements of the Federal Food, Drug and Cosmetic Act (FFDCA), including provisions related to process reforms for inspection of device establishments; the availability of over-the-counter hearing aids; enhancing generic drug competition through regulatory transparency and incentive improvements; and making technical changes to the 21st Century Cures Act. HR 2430 was approved by the Health Subcommittee by voice vote on May 18. The FDA's current user fee agreements are set to expire September 30.

Walden statement. In his opening statement, Chairman Walden said the Health Subcommittee had made several improvements to the underlying bill, "from how the FDA inspects device establishments to enhanced generic drug competition through new incentives." He said the bill will "make a number of targeted, meaningful and bipartisan steps to improve the process for generic drug approval and close loopholes that allow companies to increase prices for off-patent drugs where there is no competition. As I have said before in this room, if we do not have this bill to the President's desk in July, not only will thousands of FDA employees be seeking new employment, but desperately needed treatments and cures will not reach patients. We cannot — and will not — stand for that."

Drug Prices. At the outset of the hearing, several Democrats — including Ranking Member Frank Pallone (D-NJ), Kathy Castor (D-FL), Jan Schakowsky (D-IL) and others — asserted that the Committee should hold a hearing on high prescription drug prices. Pallone said ensuring access to affordable drugs was a bipartisan issue.

Amendments adopted

The Committee approved, all by voice votes:

— A manager's amendment by Chairman Walden that would modify the text of the underlying bill's Section 703, related to competitive generic therapy; Section 704, related to tropical disease product application, and Section 705, related to a GAO study. Among other changes, the manager's amendment adds language prohibiting any personal sound amplification product not intended for non-hearing impaired concerns from being included as part of the definition of a hearing-aid device, and clarifies that a section of HR 2430 related to state law does not affect private remedies and should not be construed to affect the "ability of any person to exercise a private right of action."

— An amendment by Scott Peters (D-CA) that would permit the HHS Secretary to approve medical imaging device applications, as long as the applications do not involve the use of certain contrast agents.

— An amendment by Ryan Costello (R-PA), reflecting the text of HR 2118, that would require the HHS Secretary to submit a report about the FDA's processes to ensure the quality and safety of serviced devices. Costello said the amendment related to "devices that have been subject to repairs and refurbished" or "improperly serviced," and as such could "cause missed diagnoses or lead to patient injury or death." Costello said the amendment "does not impose new requirements on third-party servicers."

— An amendment by Mimi Walters (R-CA) that would require the FDA to classify a medical device based on its own risk when used as intended. Walters said the amendment would "simply give the FDA an operational process to implement its existing authority … It does not change FDA's scientific decision-making process when deciding the proper classification for a device."

— An amendment by Jan Schakowsky (D-IL) that would require FDA to begin a pilot program that would provide timely and reliable information on the safety and effectiveness of certain devices, and require a report to evaluate the use of evidence. During debate, Schakowsky said that St. Jude Medical had "sold defibrillators that it knew to be faulty. Patients died due to battery failure … . We need better post-market oversight."

— Another amendment by Rep. Schakowsky that would add a provision to the bill with asense of Congress that there should be administrative and legislative changes to lower the cost of prescription drugs.

Amendments rejected

The Committee rejected, by voice vote, an amendment by Peter Welch (D-VT) that would have required the HHS Secretary to enact regulations permitting the importation of prescription drugs from Canada, with provisions requiring HHS to publish a list of certified foreign sellers on the Internet and requiring foreign sellers to pay a certification fee to cover the costs of administering the program. During debate on the amendment, Welch asked Chairman Walden if the Committee could hold a hearing on the issue of drug price negotiation. Walden said he would not commit to holding "a specific hearing on a specific piece of [the drug price issue], but we have to figure out why the costs are what they are."

Amendments withdrawn

— David McKinley (R-WV) and Rep. Welch (D-VT) offered and later withdrew an amendment that reflected the text of their HR 2018, the FAST Generics Act, which would prohibit the license holder of an FDA-approved drug or biologic from restricting its availability for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting the drug's availability with a risk evaluation and mitigation strategy (REMS). Welch said that brand drug companies "are misusing restricted distribution network requirements to deny generic and biosimilar manufacturers the products they need to get FDA approval. We want to make sure this process is fair and is not abused." He said the CBO has estimated the proposal would save $2.8 billion. Ranking Member Pallone said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, had said the agency has received 150 complaints that generics were being denied access to products, with no remedy available under current law. But Anna Eshoo (D-CA) said the amendment "conflates the samples issues with shared-system REMS … The bill as written waives the requirement for single/shared systems, which raises important public safety issues. I have a good sense of where the sponsors want to go, but the way it is drafted really needs some more work."

Rep. McKinley said that if their amendment was withdrawn, supporters should get a commitment from the chairman that "you will help us bring the pharmas back to the table, so we can have a meaningful adult conversation with them." Chairman Walden said, "I'm happy to work with you on this. There are some issues in there now that we felt needed some additional work. I'm happy to see if we can find common ground." Tony Cardenas (D-CA), Diana DeGette (D-CO) and Rep. Schakowsky also spoke in support of the amendment.

— Markwayne Mullin (R-OK) agreed to withdraw an amendment sponsored by himself, Michael McCaul (R-TX), G.K. Butterfield (D-NC) and others with the text of HR 1231, the RACE for Children Act, which would update the Pediatric Research Equity Act (PREA) to reflect the latest advances in cancer drugs. During debate over the amendment, Health Subcommittee Chairman Michael Burgess (R-TX) said he was "committed to working on the RACE for Children Act before this bill goes to the floor."

— Rep. McKinley (R-WV), who said he is "profoundly deaf" and hears with the help of a cochlear implant and a hearing aid, agreed to withdraw an amendment that would have included access to a test performed by a licensed hearing care professional under the definition of an "over-the-counter hearing aid."

— Brett Guthrie (R-KY) agreed to withdraw an amendment that reflected the text of HR 1703, the Medical Product Communications Act, which would clarify several concepts that affect how drug and medical device manufacturers can discuss truthful and non-misleading information about their products that is not included in FDA-approved labeling. Guthrie said the amendment would "allow an information exchange to provide better information-sharing on behalf of payers." Morgan Griffith (R-WV), the sponsor of HR 1703, spoke in support of the amendment. Gene Green (D-TX) and Ranking Member Pallone opposed the amendment, with Pallone saying it would "allow for communication of health care information about an unapproved drug or device as long as the manufacturer plans to submit an application." He said the measure had the potential to compromise patient safety, and "I would work on addressing this issue through regular order outside of the user fee bill."

14 Other Bills Approved

During the markup, the Committee also approved several other bills, including three health bills (HR 1222, the Congenital Heart Futures Reauthorization Act; HR 2410, the Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act; and HR 1492, the Medical Controlled Substances Transportation Act), and 11 energy and hydropower-related measures.

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ATTACHMENT

Manager's Amendment