FDA overhaul legislation could reach president by July 4

House and Senate leaders continue to try to work out differences between each chamber’s version of the Prescription Drug User Fee Act, which will authorize a 5-year extension of the FDA’s authority to assess user fees on prescription drug and medical device manufacturers.

The two bills — which significantly overhaul the FDA — also contain provisions intended to help prevent drug shortages, accelerate federal approval of generic drugs and speed up reviews of breakthrough therapies for life-threatening diseases.

The Senate approved its version May 24 by a 96-1 vote. Six days later, the House of Representatives approved a similar bill by a 387-5 margin. Members of each chamber designated to reconcile the differences between the two pieces of legislation hope to forward a compromise measure to President Obama for his approval by July 4. The FDA’s current authority to assess user fees expires Sept. 30.

Drug shortages reached record highs in recent years. The number of drug shortages tripled, from 61 in 2005 to 178 in 2010, according to an FDA report released last fall. An estimated 230 to 270 drugs went into shortage last year.

The Senate and House bills would require drugmakers to notify the government about potential drug shortages, including when they plan to discontinue or interrupt production. The federal government would have the ability to alleviate shortages by finding new suppliers, either within the country or overseas.

The legislation would give hospitals the ability to redistribute medication within their own networks, an action prohibited under current law.

The compromise legislation is expected to require drugmakers and medical device companies to pay $6.4 billion over 5 years to help cover the costs incurred by the FDA during its review of their products.

The measure also would introduce fees for the review of generic drugs and less expensive versions of biotechnology products. The generic drug fees are expected to reduce review times to a third of current levels and improve the availability of generic products for patients, according to sponsors of the legislation.

The Congressional Budget Office said the legislation would allow earlier marketing of lower-cost drugs, which would reduce the average price of drugs on the market. The CBO also estimated the legislation would save more than $750 million over 10 years in Medicaid, Medicare and federal subsidies for private insurance.