WASHINGTON | Wed May 30, 2012 7:44pm EDT
WASHINGTON (Reuters) – The House of Representatives on Wednesday approved a bill that helps fund the Food and Drug Administration and gives it new authority to prevent drug shortages and speed reviews of medical devices.
Passed by a vote of 387-5, the bill also helps ensure the safety of drugs imported from abroad by collecting higher fees from companies to fund FDA inspections of foreign facilities, and gives drugmakers incentives to make antibiotics for conditions where few treatments exist.
The Senate passed its own version of the bill last week with a near-unanimous vote, and leaders from both sides of Congress must now meet to iron out any differences. House leaders said they are aiming to agree on a final bill by July 4.
The main purpose of the bill is to reauthorize fees from makers of drugs and devices that help speed FDA evaluation of new medical products. These so-called “user fees” could make up nearly half of the FDA’s proposed $4.5 billion budget next year, according to a plan from President Barack Obama.
Since the bill provides such a large chunk of FDA funding, it is considered a “must-pass” measure that can serve as a vehicle for broader FDA-related changes.
Both the Senate and House versions, for example, give the FDA power to force drug companies to report any supply disruptions, so the FDA can work with other manufacturers to ramp up production and avoid drug shortages. Certain kinds of cancer, anesthetic, and nutrition medicines have been in persistent short supply in the past few years, often because of manufacturing problems.
Senate lawmakers say they want to work with the House to include a national system for tracking medications in order to minimize the threat of fake or stolen drugs.
The FDA has been pushing for a uniform plan that would track individual vials of medicine. But companies, distributors and pharmacies say it may be too expensive, and propose an alternative plan that would track much larger “lots” of drugs. They say their plan would pave the way for more stringent rules later.
The Senate version of the FDA bill includes room for a law that would require a uniform drug tracing system, but it may be cut if lawmakers cannot decide on the details of the plan.
The Senate and House versions of the bill disagree on some other issues, including some medical device safety provisions, and which antibiotics could qualify for incentives, depending on the medical conditions they treat.
Industry user fees, first enacted in 1992, give the FDA millions of dollars annually to review new products for the U.S. market but must be renewed every five years. The current version is set to expire in September.
Starting this year, for the first time the FDA will collect fees from makers of generic drugs and of copycat versions of complex biotech drugs, known as biosimilars.
(Reporting by Anna Yukhananov; editing by Carol Bishopric)
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