The Senate hearing dealing with FDA user fees covered much of the predictable ground, but Sen. Richard Burr (R-N.C.), a frequent critic of the agency, gave voice to the prospect that the user fee-authorizing legislation would incorporate a clawback mechanism for appropriations should the agency fail to meet the goals of the next set of user fee agreements.
The April 4 hearing of the Senate Health, Education, Labor and Pensions Committee was the second in as many weeks for the FDA user fee agreements, and committee Chairman Sen. Lamar Alexander (R-Tenn.) noted that members of the FDA management team had indicated during the previous hearing that a failure to reauthorize the programs by the end of July might force the agency to lay off staff.
Ranking Democrat Sen. Patty Murray (Washington) said she was grateful that "the dark cloud of Trumpcare" did not hang over the meeting, and that she was particularly concerned that the White House had "muzzle[d] the FDA's center directors . . . from being able to discuss the crippling consequences" of the Trump administration's hiring freeze and the regulatory two-for-one executive order.
Burr asked each of the trade association representatives at the hearing whether each of the FDA centers had met the goals agreed upon in the soon-to-expire user fee agreements. Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said that "they've made tremendous progress" toward those goals, but that the Center for Devices and Radiological Health had not met 100 percent of the metrics encoded in the third device user fee agreement.
In contrast, Kay Holcombe, senior vice president for science policy at the Biotechnology Innovation Organization (BIO), said the agency had met 100 percent of the goals in the most recent drug user fee agreement. When asked whether the FDA centers should routinely report their progress on user fee agreements to the committee, the four witnesses indicated their assent.
Burr asked Whitaker about the notion that the agency would need the resources in MDUFA IV to return 510(k) review times to historical norms, and Whitaker said that "anything we can do to return" to those traditionally shorter review times "is important. I think FDA needs to do a better job and we're committed to helping them get there," Whitaker said. Burr retorted that the agency would have made historical improvements had it complied with the requirements found in 1997's Food and Drug Administration Modernization Act.
David Gaugh, senior vice president for science and regulatory affairs at the Generic Pharmaceutical Association, noted that "cooperation between industry and FDA has never been greater," although he added, "We learned a lot from our first agreement" with the agency. Gaugh said the next generic drug user fee agreement contains a no-application-left-behind provision as a means of dealing with the generic drug backlog, explaining that the goal dates for the backlogged applications will depend on priority, albeit without elaboration.
Burr did not initially explain which funds would be clawed back in the event of a failure to meet user fee goals, and Holcombe said BIO would not be supportive "because the vast majority of the [user fee] funds . . . pay for staff at FDA, and a clawback could" cripple product reviews. Burr then clarified that he was referring to appropriations, stating, "I'm going to claw back our money. We don't have to make as bad a deal as you did."
Holcombe offered no additional comment on the idea, but Whitaker said that "we like the [device user fee] agreement as it is."
Murray noted that U.S. citizens pay more than citizens of other Western countries for prescription drugs because drugmakers need the returns to continue to invest in research and development, but she said a recent analysis by Sloan Kettering suggests the earnings are more than needed to fund R&D.
Murray inquired into transparency of drug prices, and Holcombe said pricing "is complicated. Whether we can improve the transparency" is something BIO would be willing to discuss with Congress, Holcombe said. She stated further that the price charged at the pharmacy "is not the price set by the drug company, but is the price the insurance plan is allowing to happen." She said the recent spike in drug prices was in large part due to new drugs for hepatitis, but noted that soon after those products were introduced, drug price increases began again to run parallel to other cost increases in the health care system.
Murray also took up the device safety issue, stating that duodenoscopes "led to a horrible situation. I think industry can do more to support" medical device safety. She advised, however, that she would continue to work on safety issues, perhaps an indication that she would reintroduce legislation that surfaced in February 2016. Murray declined to offer further detail, however.
Sen. Sheldon Whitehouse (D-Conn.) said he was concerned about user fee funding in the context of combination devices, which are more commonly showing up at the FDA's Office of Combination Products.
Whitehouse indicated an interest in a "third lane" for combination products, but said that "nobody having a vested interest in combination products could lead to a loss of interest."
Holcombe said drug user fee agreements provide funds for staff at the Center for Devices and Radiological Health to assist on combo product applications.
Alexander closed the hearing with remarks intended to assuage concerns over the proposed cuts to the NIH budget. "It is reassuring to remember that presidents' budgets don't ordinarily" survive congressional review, he said, noting that the Obama administration had proposed a $1 billion cut in 2016, but observed, "I think Congress has a pretty firm attitude" on NIH funding, a hint that a proposed increase of $2 billion would likely go through as planned.