Senate backs PDUFA for pharma and device reviews

A critical bill for FDA user fees has passed in the U.S. Senate. The Senate's 96-1 vote in favor of renewing the law marks a victory for drug and device companies that bank on user fees to help fund regulatory reviews of their products. And the bill provides hikes in fees as well as authorizations for makers of knockoff drugs to pony up dollars to accelerate reviews at the agency.

The House has yet to pass its own re-authorization of PDUFA to extend the user-fee act for another 5 years, yet the House version of the legislation is similar to the Senate's bill, The Wall Street Journal reported. Receiving strong support from pharma and device groups, the Senate's bill calls for a 6% hike in brand-name drugmaker fees to about $4 billion during the 5-year extension period and a doubling of fees for devicemakers.

The fees account for a major chunk of the FDA budget for medical product reviews, and advocates for reauthorizing PDUFA have also supported a provision that would provide speedier approvals. The nearly unanimous support of the bill indicates that members of the Senate have heeded a call from industry to improve the process for brining new products to market. Yet patient advocates such as Sen. Bernie Sanders, the lone vote against the Senate bill, say that the legislation falls short of providing affordable treatments for people in need.

"Today the Senate proved it could overcome election-year politics and partisanship to improve American families' access to lifesaving drugs and medical devices," Sen. Tom Harkin, a Democrat from Iowa, and Wyoming Republican Sen. Mike Enzi, said in a statement, as quoted by the WSJ. "The process that led up to today should be a model for Congressional bipartisan cooperation."

As the Huffington Post reports, the Senate bill also empowers FDA staffers to take their inspections overseas, where the majority of drug ingredients are manufactured. The bill also takes aim at reducing drug shortages and penalizing counterfeiters.

- read the WSJ article
- and the Huffington Post's report