FDA User Fee Legislation Approved by Senate Panel

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By Bronwyn Mixter

Legislation to reauthorize the FDA’s user fee programs was advanced May 11 by a Senate panel.

The Senate Health, Education, Labor and Pensions Committee voted 21-2 to approve the legislation (S. 934). Sens. Bernie Sanders (I-Vt.) and Rand Paul (R-Ky.) voted against the bill. Before voting, the committee unanimously adopted the manager’s amendment released May 8, which adds provisions on pediatric drugs and devices, bioequivalence and device inspections and regulation. The bill now goes to the full Senate for consideration. The current authorization for the user fees expires Sept. 30.

Sen. Lamar Alexander (R-Tenn.), chairman of the committee, said he wants the bill to go to the president’s desk by the August recess. Otherwise, he said, the FDA would have to send layoff notices to more than 5,000 employees to notify them they could lose their jobs in 60 days. He also said a delay in reauthorizing the fees would harm patients and families that rely on medical innovation and “would threaten biomedical industry jobs and America’s global leadership in biomedical innovation.”

Industry pays user fees to help fund Food and Drug Administration operations. The agency has separate user fee programs for prescription drugs, generic drugs, biosimilars and medical devices. In return for the fees, the agency commits to meet certain performance goals. The legislation would reauthorize the programs for fiscal years 2018 through 2022.

Alexander also said some of the senators on the committee have requested a hearing on drug costs and he and Sen. Patty Murray (D-Wash.), the ranking member of the committee, have agreed to hold a hearing on this soon.

Health-Care Reform

Some Democratic senators also used the markup as an opportunity to express their concerns about legislation to repeal and replace Obamacare.

Murray said the bill passed recently in the House, which she referred to as “Trumpcare,” would end the guarantee of essential health benefits and increase premiums by as much as 20 percent. She said she’s disappointed the HELP Committee hasn’t yet held a hearing “to talk about exactly what Trumpcare would mean.”

The House May 4 passed the American Health Care Act ( H.R. 1628), sending it to the Senate.

Sen. Christopher Murphy (D-Conn.) said he is concerned that the Senate version of the health-care reform bill won’t be considered in the committee before reaching the Senate floor. “I understand there isn’t a plan to have a full committee process on an Obamacare repeal and replace bill and I can’t live with that. Just because it’s hard doesn’t mean this committee becomes irrelevant,” Murphy said.

Sen. Elizabeth Warren (D-Mass.) agreed that the committee should hold a hearing on the health-care bill and said, “if Republicans want to lower costs and improve access [to health care], I’m ready to roll up my sleeves and get to work.”

Amendments on Generics, Clinical Trials

Two amendments to the user fee bill—which would improve access to generic drugs and improve clinical trials for experimental medical treatments that have life-saving potential—were approved by voice vote.

A separate amendment, offered by Sanders, that would have allowed Americans to import prescription drugs from Canada was tabled by a vote of 13-10 due to its controversial nature.

Alexander said before the votes that it was important to keep the user fee bill bipartisan and noncontroversial so that it could be sent to the president’s desk by August.

The generic drug amendment, offered by Sens. Susan Collins (R-Maine) and Al Franken (D-Minn.), “takes a number of steps to foster a more competitive generic marketplace. Generic drug competition is key to lower prices,” Collins said. Among other things, the amendment would set a clear time frame for the FDA to prioritize its review of generic drugs in cases where there isn’t adequate competition. It also would improve transparency on the FDA’s backlog of generic drug applications and provide additional support and communication to help improve the quality of generic applications on the front end.

The clinical trials amendment, offered by Sens. Orrin G. Hatch (R-Utah), Michael F. Bennet (D-Colo.), Richard Burr (R-N.C.) and Robert P. Casey (D-Pa.), would require the FDA to hold a public meeting to discuss clinical trial inclusion and exclusion criteria and issue a report to Congress. It would also require the FDA to issue draft guidance on eligibility criteria for clinical trials.

Pediatric Cancer Drugs

Bennet also offered an amendment, which he immediately withdrew, that would support the development of cancer drugs for children. The amendment stemmed from his bill ( S. 456), the Research to Accelerate Cures and Equity (RACE) for Children Act. Bennet, along with Sens. Marco Rubio (R-Fla.), Chris Van Hollen (D-Md.) and Cory Gardner (R-Colo.), introduced the bill in February.

The bill would update the Pediatric Research Equity Act (PREA) to reflect the latest advances in cancer drugs, according to a press release on the bill. PREA was enacted by Congress in 2003 to address the scarcity of information about how to treat children with drugs developed for adults. It sought to develop pediatric data during drug development.

Bennet said in a May 11 statement he will continue to work to advance this bill.

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

For More Information

The bill is at http://src.bna.com/oFA.

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