PDUFA V becomes law

Shortages in final bill, but not hydrocodone rescheduling and track and trace

Reauthorizing the Prescription Drug User Fee Act (PDUFA V), President Barack Obama signed the FDA Safety and Innovation Act (S. 3187) into law on July 9.

“While enactment of S. 3187 marks an important moment for innovators across industry, research, and clinical care settings, its most important beneficiaries are the patients and families that will be helped by the next generation of affordable medical products this bill will help to foster,” Kathleen Sebelius, Secretary of the U.S. Department of Health & Human Services (HHS), said in a statement

Following a deal by negotiators from the U.S. House of Representatives and the U.S. Senate on the fifth reauthorization of PDUFA, 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.

Congress rushed to pass the bill before the Supreme Court handed down its June 28 ruling mostly upholding the Affordable Care Act (ACA) 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.

Final bill

The law reauthorizes FDA’s ability to collect user fees 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 such applications; the agency’s additional funding comes through congressional appropriations.

Representing more than $5.6 billion in fees paid by manufacturers to FDA, the law 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 requirements related to drug shortages, including early notification by manufacturers of FDA of potential shortages and an HHS-maintained public list of all drugs experiencing shortages; and Government Accountability Office studies related to shortages, illegal “pharmacy” websites, and electronic professional labeling.

More key provisions of the law include the authorization of HHS to develop guidance on standards for interoperability of prescription drug monitoring programs; increased manufacturer-level track-and-trace provisions; establishment of a working group of pharmacists, patient advocates, and federal regulators to establish best practices for pharmacies to ensure that people who are blind or visually impaired have access to prescription drug labeling; and the permanent reauthorization of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act and the creation of the Creating Hope Act.

Included in January’s PDUFA V agreement between FDA and manufacturers, which describes how the agency 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.

APhA was active on the PDUFA reauthorization both on the regulatory side and as it wound its way through Congress. On April 24, the Association sent a letter to Senate Health, Education, Labor, and Pensions Committee leadership in support of the program and the then-proposed legislation. On May 21 and 22, the Association was involved in activity on multiple fronts urging senators to vote against any drug importation amendments; in the end, one drug importation amendment was voted on, but did not pass the Senate.

“We are happy with the final result and what is in—and what is not in—the final package,” Spira said.

What’s out

One provision that didn’t make it into the final bill is downstream supply chain security to the pharmacy, 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.

Another provision not in the final bill was the reclassification of all hydrocodone-containing products to Schedule II, the subject of an amendment to the bill when it passed the Senate. The final bill did require FDA to hold a public meeting on the issue that the agency has scheduled for October 29–30.

While hydrocodone-only products are already Schedule II, products combining hydrocodone with certain other drugs are Schedule III. Under a reclassification, patients would need an original prescription for refills, the products would be stored and transported more securely, and traffickers would be subject to increased fines and penalties.

While prescription drug abuse and diversion are concerning and unfortunate, “these concerns must be balanced with the impact on patients who legitimately need access to these products,” according to May 30 letters to House and Senate offices signed by five pharmacy groups, including APhA. The letters added that burdens to pharmacies would increase.