On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934.  The committee voted almost unanimously to move the bipartisan bill forward, with only Senator Bernie Sanders (I-Vt.) and Senator Rand Paul (R-Ky.) voting against it.  And in an interesting overlap of FDA-related news, the Agency’s brand-new Commissioner, Dr. Scott Gottlieb, was also sworn in on May 11th following a speedy (albeit politically controversial and party-line) confirmation process and Senate vote.  With less than a week on the job, Dr. Gottlieb is already receiving pressure from varied stakeholders to ensure the user fee legislation is enacted in a timely manner in order to avoid disrupting the Agency’s work.

As regular readers of this blog know, FDARA would reauthorize FDA’s authority to collect user fees from developers of pharmaceuticals, medical devices, generic drugs, and biosimilars, the authority for which are all set to expire at the end of September 2017 (see prior posts here and here).  The bill passed out of the HELP Committee now goes to the Senate floor for a vote.  Although the timing of that vote is unclear, it may be fair to assume it will be scheduled relatively soon given how quickly Congress is working to finalize these important UFA reauthorizations.  On the House side, the Energy & Commerce Committee has not yet scheduled the legislation for consideration and markup.

Critically, the HELP Committee released a manager’s amendment a few days before the vote that added several substantive policy amendments to the original “clean” discussion draft of FDARA.  The manager’s amendment did not incorporate any of the more controversial bills and provisions about which we have previously speculated.  For example, legislation aiming to address lab-developed tests, REMS reforms, and off-label drug promotion was not included.  But the amendments to FDARA’s baseline reauthorization provisions did include:

  • A requirement for FDA to develop bioequivalence guidance specific to complex generic drugs.
  • Three of the medical device policies we discussed previously, that provide for risk-based inspections of medical device facilities, changes to the regulation of contrast agents for use with imaging systems, and OTC sales of certain hearing aids to consumers.
  • A bill intended to spur earlier planning and completion of pediatric studies to support industry’s development of pediatric drug products.
  • Technical changes to the Orphan Drug Act intended to codify FDA’s interpretation of the “clinical superiority” requirement, which has been challenged by applicants in court over the past several years.

In addition to the policy riders that were added to FDARA via the manager’s amendment, HELP Committee members added two more provisions by voice vote during the May 11th markup hearing.  The first amendment would require FDA to hold a public meeting and develop guidance with the goal of increasing patient access to experimental drugs.  This language may have been developed with the intent to forestall the likelihood of a more controversial Federal “Right-to-Try” bill being attached to the user fee package.  And the second amendment would direct FDA to expedite its review of certain generic drug applications, although some observers point out that this amendment is symbolic in nature because the Agency has already taken procedural steps towards a similar policy goal.

On the other hand, Senator Sanders’s amendment to allow Americans to import prescription drugs from Canada was tabled during the markup hearing, as a result of its controversial nature.  HELP Committee Chairman Lamar Alexander has been clear since the beginning of this process that he wants to keep FDARA bipartisan and free of controversy, so that it has the best chance of getting through both chambers of Congress before the end of the July.  More recently, Chairman Alexander (R-Tenn.) has indicated that controversial amendments may be considered during the full Senate’s upcoming floor vote on the bill.  Thus, whether any specific “drug pricing”-related proposals make it onto FDARA remains to be seen.

Finally, although we have been focusing on the policy riders and new FDA provisions that may be attached by Congress to the user fee package, it is worth reiterating here that the user fee agreements themselves make significant changes compared to the previous 5-year iteration of these four programs (PDUFA, MDUFA, GDUFA, and BsUFA).  For example, fees for supplemental drug and biologic applications have been phased out but some new fees have been created (such as a new fee for de novo medical device applications), and fee consolidation could mean that individual companies may have to pay more in total.  Industry stakeholders should be aware of these programmatic changes and determine the potential impact on their business plans or any existing agreements with manufacturing, distribution, or development partners.

As always, we will continue to follow these important legislative developments and related news from FDA and its new Commissioner Dr. Gottlieb.