Senate Passes Bipartisan Bill on New Medicines
By Robert Pear, New York Times
May 24,2012, WASHINGTON — The Senate on Thursday passed a major bipartisan bill to prevent drug shortages and to speed federal approval of new lifesaving medicines, including lower-cost generic versions of biotechnology products.
A similar bill is on a fast track to approval in the House, perhaps as early as next week. President Obama, consumer groups and pharmaceutical companies strongly support the legislation.
The measures reflect the government’s effort to keep up with new therapies developed from a decade of rapid progress in biomedical research. After months of legislative paralysis and political sniping, the sight of Democrats and Republicans working together on a major bill was surprising.
The Senate bill passed by a vote of 96 to 1; the only no vote was cast by Senator Bernard Sanders, independent of Vermont.
The measure would increase the government’s reliance on user fees, requiring makers of drugs and medical devices to pay $6.4 billion over five years to finance the evaluation of their products by the Food and Drug Administration.
The bill reauthorizes user fees for brand-name drugs and medical devices and introduces fees for the review of generic drugs and less expensive versions of certain biotechnology products, known as biosimilars.
The chief sponsor of the bill, Senator Tom Harkin, Democrat of Iowa, said the fees for generic drugs “are expected to slash review times to a third of current levels, from 30 months to 10 months, and will improve the speed with which generic products are made available to patients.’’
Mr. Harkin, the chairman of the Senate health committee, wrote the bill over the last 18 months with Senator Michael B. Enzi of Wyoming, the senior Republican on the panel.
About 60 percent of the money for the review of new drug applications already comes from industry fees, which are used by the F.D.A. to hire scientists and buy equipment. If Congress does not act, the agency would have to lay off some employees.
The bill would impose new requirements on drug makers to notify the government of potential drug shortages, which have become common in recent years. Federal officials would have to take steps to “help mitigate or prevent’’ the shortages, perhaps by finding other sources of supply, in this country or abroad. Manufacturers would also have to inform the F.D.A. before shutting down production of certain drugs.
Senators of both parties said they had received pleas for help from constituents affected by shortages of drugs like cytarabine for leukemia, Doxil for ovarian cancer and methotrexate for various diseases.
The Senate majority leader, Harry Reid, Democrat of Nevada, said the concern was personal because his wife was being treated for breast cancer.
“Through 20 weeks of chemotherapy,’’ Mr. Reid said, “my wife, Landra, and I lived with the fear that the medicine she needed every Monday morning wouldn’t be there because there were shortages. Fortunately for us, the drug was always accessible. But many Americans have not been so fortunate. People die as a result of not having the medicines.’’
The Senate Republican leader, Mitch McConnell of Kentucky, said, “This is an incredibly complex piece of legislation that strikes a difficult balance, protecting consumers while avoiding the stifling regulation that slows the process of bringing drugs and devices to market.’’
Democrats from states with thriving drug and device industries, like Minnesota and New Jersey, joined Republicans in saying they wanted to nudge the F.D.A. to accelerate the review of new products without jeopardizing patients’ safety.
The Congressional Budget Office said the bill “would lead to earlier marketing of lower-priced drugs,’’ reducing the average price of drugs in the market and saving more than $750 million over 10 years in Medicare, Medicaid and federal subsidies for private insurance under the new health care law.
Over the next five years, the budget office said, the F.D.A. would collect $4.1 billion in fees for review of brand-name prescription drugs, $1.6 billion for generic drugs, $609 million for medical devices and $128 million for less costly versions of biotechnology products.
The legislation sets performance goals for the agency, including deadlines that would reduce the time it takes for new products to reach the market. The goals were negotiated by the agency and drug and device companies.
Senator Richard M. Burr, Republican of North Carolina, said this arrangement was highly unusual. “Typically,’’ Mr. Burr said, “legislation is crafted in Congress, not negotiated in the back room of the F.D.A. with device and pharmaceutical manufacturers. Congress is effectively shut out of the process until a deal negotiated behind closed doors is announced.’’
The bill would create expedited procedures for the review of “breakthrough drug therapies’’ for life-threatening diseases. It would create incentives for development of new antibiotics to treat infections caused by germs resistant to existing drugs.
The bill also requires more frequent inspection of foreign companies that produce drugs imported into the United States; increases criminal penalties for the sale of counterfeit drugs; and requires pharmaceutical companies to keep track of each batch of their drug products from the factory to the pharmacy.
After passing the drug bill, the Senate was expected to defeat separate Republican and Democratic proposals to protect college students against an increase in interest rates on federal loans. The rate is scheduled to double to 6.8 percent on July 1. Senators disagree on how to pay for the measure.