Story updated July 14, 2017
The House of Representatives passed bipartisan legislation Wednesday that reauthorizes the FDA's ability to collect user fees from drug and device makers, as policymakers look to avoid thousands of layoffs if the current agreement expires.
The FDA user-fee agreements, which are renegotiated every five years with the makers of prescription brand drugs, medical devices, generic drugs and biosimilars, fund much of the FDA's operations.
The bill calls for more than $400 million in new user fees in fiscal 2018, and would incrementally increase fees each year thereafter. It would allow the FDA to hire more staffers and speed up approvals of drugs and devices, which could help healthcare companies streamline operations, supporters argue. Yet, critics claim that the rising fees disproportionately affect smaller companies, and expediting the review of drugs and medical devices could compromise quality.
"It gives the FDA predictable resources and allows the industry to have a better understanding of when the FDA will complete reviews, which is very important," said David Rosen, a former FDA official and current head of the FDA regulatory practice group at law firm Foley & Lardner.
Both the Advanced Medical Technology Association, which represents devicemakers, and the Pharmaceutical Research and Manufacturers of America, which represents drugmakers, are on board with the latest user-fee legislation.
"The robust performance goals, process improvements, increased accountability and additional resources built into the new user-fee agreement mean that patients will benefit from more timely access to the latest medical innovations and companies will benefit from greater certainty as they plan for the next-generation of advancements," AdvaMed CEO Scott Whitaker said in a statement.
The bill has been amended slightly since it breezed through the Energy and Commerce Committee last month to include provisions related to pediatric drugs and devices. There are around 900 treatments in the works for adults with cancers, but only a handful are tested for children.
The Research to Accelerate Cures and Equity for Children Act would eliminate current exemptions that allow drug and device developers to forgo pediatric studies of certain molecularly targeted cancer drugs. Supporters hope it would create an incentive for the pharmaceutical industry to develop new pediatric oncology treatments. Under the current system, some pediatric cancer drugs take decades to develop and get approved, Rep. Joe Barton (R-Texas) said at the hearing.
"This will make it possible to help children sooner," he said. "How many thousands of children have died while these drugs were being developed?"
Another amendment aims to curb abusive pricing on pharmaceuticals without generic competition. It provides a six-month exclusive rights period to any generic manufacturers who choose to compete against an off-patent drug that currently has no competition. Currently, that exclusivity is only available to a first entrant.
The proposed generic drug fee structure aims to provide more predictability for the FDA and flexibility for small businesses. Fees would also scale to the number of applications a company submits, which is an important element, Rosen said.
Other provisions include easing requirements for medical imaging devices, creating a pilot project to evaluate the post-market safety of medical devices, forming a new regulatory class of hearing aids that could be sold over the counter and adjusting the risk-based classification of medical devices in an effort to improve the predictability of review times.
"Legislation must be approved in timely fashion to avoid a meltdown of the medical product development pipeline," Rep. Gene Green (D-Texas) said.
The user-fee program must be reauthorized by the end of September, or the FDA will have to lay off more than 5,000 employees. A delay also would postpone the review of many drugs and devices.
The Senate Health, Education, Labor and Pensions Committee in May approved a user-fee bill, but the full Senate has yet to take action, and the window is closing given an already packed agenda that includes repealing and replacing the Affordable Care Act, addressing the debt ceiling, and passing a budget. House and Senate versions of the will have to reconciled before being sent to the president.
"This legislation will save lives," House Energy & Commerce Committee Chairman Greg Walden (R-Ore.) said.
An edited version of this story can also be found in Modern Healthcare's July 17 print edition.
