FDARA Takes Effect With Under-The-Radar Presidential Signature

Key FDA legislation moves to implementation phase with presidential signature but little fanfare.

The FDA Reauthorization Act now stands as one major piece of health legislation becoming law under President Trump, even though the White House did not make a big deal of it.

Trump signed the bill Aug. 18, but it was largely unnoticed amid news about the departure of Steve Bannon from the White House staff and other hot-button US news developments.

FDARA reauthorizes FDA's prescription drug, medical device, generic drug and biosimilar user fee programs for another five years, beginning Oct. 1. It earlier cleared the House and Senate with overwhelming majorities. (Also see "Implementing User Fees Should Be Lighter Lift For FDA This Time Around; Bill Heads To White House" - Pink Sheet, 3 Aug, 2017.)

The law also makes several policy changes intended to streamline generic drug approvals, as well as adjust expanded access rules and tighten some orphan drug exclusivity requirements.

The bipartisan congressional support for FDARA and successful signing into law (albeit just hours before it would have taken effect by default anyway, absent a not-anticipated presidential veto) contrasts with the breakdown so far in efforts to repeal and replace the Obama health reform law.

The successful conclusion is especially welcome to FDA stakeholders given criticisms Trump early on raised with the FDA/industry negotiated agreements on user fee renewals. He said that industry should instead be paying most of the cost of drug review, since it is benefiting from the service

Trump's signature on the bill suggests White House confidence FDA's direction under Commissioner Scott Gottlieb.

"FDA is an agency that is critical to the well-being of every American and it needs the support of this administration in addition to any support that comes from industry provided user fees," former FDA Commissioner Andrew von Eschenbach commented the Pink Sheet Aug. 18.

"The FDA Reauthorization Act contains provisions that will enable the Agency to continue the work of modernization of a 21st century regulation of safe and effective food and drugs. After being passed almost unanimously by both the Senate and House of Representatives this bipartisan bill should be signed into law!"

A Win For Drug Pricing Agenda?

Trump did not hold a signing ceremony or offer much celebration for what could also be called a step forward in the drug pricing debate. (Also see "FDARA: The Forgotten Health Care Bill" - Pink Sheet, 19 Aug, 2017.)

Trump has said he wanted to lower drug prices and FDARA includes provisions aimed at that goal. (Also see "Who Speaks For The White House On Drug Prices? Industry Better Hope It Is Not Donald Trump" - Pink Sheet, 14 Mar, 2017.)

Pharmaceutical Research and Manufacturers of America President and CEO Stephen Ubl said in a statement that enacting FDARA was "increasing competition in the biopharmaceutical market.

Members of Congress also have framed FDARA as a drug pricing bill in addition to an FDA policy update. It would create a priority review and breakthrough-style pathways for generic drugs in support of a popular congressional stance that increased competition will bring prices down (see sidebar).

Indeed, leadership of the House Energy and Commerce Committee, which shepherded the bill through that chamber, immediately praised the signing in a bipartisan statement, saying among other things that the legislation would "bring lower cost drugs to market faster."

In addition, FDA in recent weeks changed internal policy to prioritize ANDAs for reference products with fewer than three approved generics. (Also see "FDA Drug Pricing Policy Offers Short-Term PR Gain, More Long-Term Actual Benefit" - Pink Sheet, 27 Jun, 2017.)

Senators were interested in potentially moving separate drug pricing legislation, but after a hearing on the subject devolved into complaints about reforming Obamacare, subsequent hearings were postponed. (Also see "Drug Pricing Hearing In Senate Postponed, Handing Innovators Another Victory" - Pink Sheet, 29 Jun, 2017.)

Signing Came At Nearly Last Minute

Trump waited until the end of the 10-day period allowed following congressional approval, excluding Sunday, before placing pen to paper. However, because Congress remains in session, the bill would have become law no matter Trump's action.

In addition to criticizing the FDA/industry fee agreements, the White House also had said that it opposes provisions in the bill that would expand generic drug exclusivity. (Also see "White House Slams Generic Exclusivity Provisions In User Fee Bill" - Pink Sheet, 14 Jul, 2017.)

If the bill had not been enacted, FDA would have been forced to unwind the user fee programs and lay off hundreds of employees. The agency almost was forced to send notices to employees that may be affected earlier this month, but decided against it after receiving assurances that the bill would be enacted expeditiously. (Also see "FDA Gives Congress Reprieve On Deadline For Passing User Fee Bill" - Pink Sheet, 25 Jul, 2017.)