Pharmacy groups pleased with House approval of PDUFA reauthorization

Pharmacy groups supported yesterday’s approval by the U.S. House of Representatives of the FDA Safety and Innovation Act of 2012, also known as the Prescription Drug User Fee Act (PDUFA).

This legislation reauthorizes drug and medical-device user-fee programs for 5 years and establishes new user fees for FDA’s review of generic drugs and biosimilar agents. The measure, which was approved by a voice vote, will return to the U.S. Senate for approval.

“Advancing this legislation is important for patient care now and into the future, and NACDS commends Congress for its efficiency in moving it forward,” said NACDS President and CEO Steven C. Anderson, IOM, CAE. “As expected the legislative process also provided for opportunities to consider options on issues ranging from supply chain security, to drug abuse and diversion. The final bill includes positive steps forward on these issues.”

The legislation is expected to raise the fees the pharmaceutical industry and device companies pay the FDA for safety and efficacy reviews. Manufacturers of brand-name drugs have paid fees since 1992 and device makers have contributed fees since 2002. This bill also requires user fees for generic drugs and biosimilar agents.

In its press release, NACDS outlined important provisions in the legislation that pertain to patient care:

■ Creation of increased requirements, inspections, and oversight for domestic and foreign facilities that manufacture drugs and ingredients.

■ Ability of FDA to destroy counterfeit or adulterated imported drug products and increase the penalties associated with drug counterfeiting and intentional drug adulteration.

■ Development of a report by the Secretary of Health and Human Services (HHS) to identify current federal initiatives, gaps, and opportunities with respect to ensuring the safe use of prescription drugs with the potential for abuse. The report would include findings and recommendations on how to leverage and build upon existing federal and federally funded data sources, such as prescription drug monitoring program data and the FDA’s Sentinel initiative.

■ Examination by the Government Accountability Office (GAO) of problems posed by online websites that violate state or federal law. It is hoped that the study will address how illegitimate websites operate, the harm to patients, and whether additional authorities could assist federal, state, and local governments.

■ A public meeting by FDA, within 60 days of enactment of the law, on the rescheduling of combination hydrocodone products.

The bill does not include a Senate provision that would have restricted patient access to hydrocodone products. Also, a provision to require drug companies to put traceable identification numbers on all packaging was removed.

“This critical legislation addresses several issues of importance to patients and the independent community pharmacists who serve them,” said NCPA CEO B. Douglas Hoey, RPh, MBA. “Key provisions in this bill help address shortages of essential medicine as well as the abuse of prescription drugs, while doing so in a way that does not increase costs or undermine pharmacists’ ability to care for patients.”

In its press release, NCPA highlighted the following provisions:

■ A requirement by the Drug Enforcement Administration to provide timely approvals or denials of manufacturer requests for increases of quotas of Schedule II controlled substances to help alleviate a drug shortage situation.

■ A requirement by the GAO to conduct a study to examine the causes of drug shortages and issue recommendations on the prevention or alleviation of them.

■ Ability of the Secretary of HHS to facilitate the exchange of prescription drug monitoring programs across state lines to prevent drug abuse. Also, HHS would study the problem of rogue, online pharmacy websites.

■ The development of best practices on the issue of accessibility of information in prescription drug labeling for visually impaired and blind patients.

NCPA wants to continue its work with Congress to address the track-and-trace issue and the reduction of the abuse of prescription drugs, such as hydrocodone. These 2 issues were not included in the final legislation, NCPA noted.