Despite repeated calls for a fix for the drug pricing problem that held up the proceedings, a House subcommittee met May 18 to mark up FDA user fee legislation, which is headed to the full Energy and Commerce Committee with amendments that would boost generic drug competition and press the agency on medical device inspections.

Rep. Michael Burgess, chairman of the Energy and Commerce's health subcommittee, said at the outset of the hearing that "it is a priority to complete this work . . . in a timely manner." The members of the subcommittee were widely unwelcoming of a repeated proposal by the Trump administration to reopen the user fee negotiations, a proposal that would have doubled the amount the agency expects to collect in user fees during the current fiscal year, which some estimate at roughly $1 billion.

Rep. Frank Pallone, ranking member of the full Energy and Commerce Committee, voiced his opposition to the White House's proposal, and he was one of several Democrats on the subcommittee that took up the drug pricing question. Pallone claimed that roughly one in five Americans between the ages of 19 and 64 are unable to afford at least some prescribed medications, and called for "a serious policy discussion" on the matter "to learn more about what can be done to make prescription drugs more affordable for patients and their families."

Without directly referring to the Trump administration's user fee gambit, Burgess said "it is important" that the user fee bill pass expeditiously in order to avoid layoffs at the FDA.

User fee legislation underwent a similar scrubdown in the Senate committee of jurisdiction on May 11, a hearing peppered with discussions of drug reimportation. That hearing included an amendment to bolster generic drug competition with brand names, although the Senate Health, Education, Labor and Pensions bill carried a provision that is not seen in the House bill at present, a provision that would seem to expand enrollment requirements for drug and device clinical studies. (See BioWorld Today, May 12, 2017.)

Rep. Gus Bilirakis (D-Florida), said the Lower Drug Costs Through Competition Act (H.R. 749) creates a new competitive generic drugs program, noting that only one in 11 generics are approved on the first review cycle. Bilirakis, whose father served in the Florida congressional delegation for 24 years, remarked that a generic that has to go through three review cycles may not see the market until five years have passed, noting that his bill would creates an exclusivity incentive to create generics when none are available to compete with the original NDA.

Burgess said he "urge[s] my colleagues to support" the amendment, which passed on a voice vote.

H.R. 1736, the FDA device inspection bill sponsored by Reps. Larry Buschon (R-Ind.) and G.K. Butterfield (D-N.C.) likewise passed on a voice vote. Butterfield said the bill would protect public health by ensuring "the FDA is making the best use of its resources," citing the "vast discrepancies of inspections" of device manufacturing facilities "simply because of where they are located." Butterfield was referring to complaints by device makers that inspections of domestic facilities are often interrupted and drawn out due to for-cause inspections of other sites, a problem not seen with inspections of sites located outside the U.S.

H.R. 1222, the Congenital Heart Futures Reauthorization Act of 2017, reauthorizes a bill first passed in 2010, and sustains federal coordination of research into congenital heart disease. That bill passed on a voice vote, as did H.R. 2410, the Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2017. As is the case with the congenital heart disease bill, H.R. 2410 would fund federal government surveillance of the disease in question, but would also implement public health initiatives. Burgess said the legislation "will move us one step closer to improving the quality of care" for those with sickle cell disease.

H.R. 2118, the Medical Device Servicing Safety and Accountability Act of 2017, did not make it aboard the user fee bill as passed by the subcommittee, although Rep. Billy Long (R-Mo.) touted the bill as one that will protect patients from subpar third party servicing of radiology equipment. Rep. Anna Eshoo (D-Calif.) spoke in support of the bill as well, but Long conceded the subcommittee field of play, stating that he will make the case for H.R. 2118 at the full committee markup.

The Over the Counter Hearing Aid Act of 2017 (H.R. 1652) also did not make it aboard the user fee bill as passed onto the full committee, but Rep. Joe Kennedy (D-Mass.) said he and the bill's other sponsors will work on the language of the bill to address outstanding concerns. Burgess spoke in support of the bill, remarking that Jeff Shuren, director of the FDA's device center, was one of several who had "unequivocally agreed" with comments that OTC hearing aids would be safe and effective, and that there is no scientific basis for screening as a condition of purchase of OTC hearing aids.

Burgess proposed an amendment, the Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376), which he said is "narrowly tailored" to keep counterfeit and diverted drugs out of the U.S. He said the penalties for counterfeiting would become the same as those for diversion. The bill "will make minor additions to the statute by closing loopholes," he said, but the amendment received no vote.

H.R. 2026, the Pharmaceutical Information Exchange Act of 2017, likewise gained some bandwidth during the hearing, but was not put to a vote. Rep. Brett Guthrie (R-Ga.) said the bill addresses the issue of communication with payers and formulary managers, and Rep. Greg Walden, chairman of the full Energy and Commerce Committee, voiced his support with the remark that he sees "no good reason we should continue the status quo."