Congress sends PDUFA V to Obama

Provisions on shortages, pediatric drugs make it into final bill, but those on hydrocodone rescheduling and track and trace do not.

Following a deal by negotiators from the U.S. House of Representatives and the U.S. Senate on the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V), the House passed the legislation on June 20 by a voice vote and the Senate passed it on June 26 by a vote of 92–4.

President Barack Obama is expected to sign the bill into law this week; technically, he has until the end of September, when PDUFA IV expires.

Congress rushed to pass the bill before the Supreme Court hands down its ruling on the Affordable Care Act (ACA) on June 28 because of a fear that PDUFA would have become a “Christmas tree” on which people could hang health care reform–related initiatives in the wake of the court’s decision, according to APhA Senior Lobbyist Michael Spira.

PDUFA was the year’s most bipartisan legislation to date, Spira added.

The legislation reauthorizes FDA’s ability to collect user fees to pay for brand-name prescription drugs and medical devices, and creates two new user fee programs for generic drugs and for biosimilars (generic biologics). User fee programs allow FDA to collect user fees from industry to help fund the agency’s timely review of drug applications.

Representing more than $5.6 billion in fees paid by manufacturers to FDA, the legislation includes more than $700 million in fees related to brand-name drugs for fiscal year (FY) 2013 and higher amounts for FY 2014–17, according to a committee report. The user fee program for medical devices would bring in $595 million for FY 2013–17. For generics, the generic drug industry would pay approximately $1.5 billion for FY 2013–17. The user fee program for biosimilars would apply to products approved under the abbreviated pathway in ACA.

Among the key additional provisions are the permanent reauthorization of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act; requirements related to drug shortages including early notification by manufacturers of FDA of potential shortages, which was championed by the American Society of Health-System Pharmacists; and Government Accountability Office studies related to shortages, illegal online pharmacy websites, and electronic professional labeling.

Included in the PDUFA V agreement between FDA and manufacturers (on how FDA intends to use the fees) was language on standardizing Risk Evaluation and Mitigation Strategies (REMS), including maximizing effectiveness while limiting burdens; advancing the use of biomarkers and pharmacogenomics for serious diseases; and expanding FDA’s Sentinel system.

Provisions that didn’t make it into the final bill include rescheduling of hydrocodone; requirements for pharmacies to provide labeling to patients who are visually impaired and blind; and downstream supply chain security, specifically track and trace.

Track and trace is not dead, according to Spira. Conversations around the issue are ongoing among stakeholders and Members of Congress. The hope is to have an agreement to include in other health care legislation.