It is now up to the House.
The Senate Thursday voted 96-1 vote in favor of re-authorization of PDUFA. It now goes to the House, whose own version to extend the user-fee act for another 5 years is similar to the Senate's bill, The Wall Street Journal reports.
The Senate version would put in place the long-discussed increases in fees from drug- and devicemakers to get faster reviews of their products, and loop in genericsmakers who previously were exempt from the fees. But the bill also gives the FDA new authorities. It will allow them tighter controls to regulate foreign drugmakers, a large concern in recent years in the face of tainted products from overseas. It would also give the agency leverage to inspect the manufacturing plants of foreign companies, or to block their products if they refuse. It also puts the responsibility on drug manufacturers to audit their suppliers to insure that their APIs meet U.S. standards.
The Senate bill also takes on the issue of drug shortages, setting out requirements for drugmakers to notify the FDA of potential drug shortages and for the agency to look for alternative sources of supply when they do. Shortages have gotten worse in recent years, and affected patients have been calling on members of Congress for help, points out The New York Times. The bill also looks to shorten review times for drugs in an effort to get potentially life-saving treatments to the market faster, a measure that is controversial because of the chance the risks will be overlooked in the process.
Financially, the Congressional Budget Office has said the bill could save Medicare and Medicaid more than $750 million over 10 years by getting lower-priced drugs to the market faster. It also projects collecting, over 5 years, $4.1 billion in fees for reviewing branded drugs, $1.6 billion for generics and $609 million for medical devices, the Times reports. It also would collect $128 million for less-costly versions of biosimilars.
The House may vote on its bill as early as next week.
- read the Wall Street Journal story
- here's The New York Times' take