Biotech generics bill introduced in Congress

March 16, 2009

A bipartisan bill that would allow the U.S. Food and Drug Administration (FDA) to approve affordable copies of biotech drugs has been introduced in Congress.

A bipartisan bill that would allow the U.S. Food and Drug Administration (FDA) to approve affordable copies of biotech drugs has been introduced in Congress. Reps. Henry A. Waxman (D-CA), Frank Pallone (D-NJ), Nathan Deal (R-GA), and Jo Ann Emerson (R-MO) introduced H.R. 1427, the Promoting Innovation and Access to Life-Saving Medicine Act.

Currently, the FDA lacks clear guidelines or authority to approve generic versions of biotech drugs. This has allowed companies to charge relatively high prices even after patents have expired. Generic-industry executives and some consumer groups believe introducing competition for biotech drugs is essential to keeping these life-saving treatments affordable.

“I believe this bill will lead to healthy competition and long-term savings for patients and payers, and will preserve innovation in the biotech marketplace,” said Waxman, Chairman of the House Energy and Commerce Committee. “Above all, this bill guarantees that FDA has the scientific discretion to hold these drugs to the same high standard to which the original products are held.”

The bill would give FDA authority to ensure that any approved copy of a biotech drug is just as safe and effective as the original product, and provides the makers of new biotech drugs ample incentives for continued innovation.

The bill is consistent with the legislation described in President Obama’s proposed budget. Specifically, the bill amends section 351 of the Public Health Service (PHS) Act to authorize the Secretary of Health and Human Services to approve abbreviated applications for biological products that are “comparable” to previously approved biological products.

An application for comparable biological products must show there is no clinically meaningful difference between the two products regarding safety or effectiveness, according to the bill. The application must also show that the biogeneric and reference product contain “highly similar principal molecular structural features.”

“While biologics are highly effective medications in the treatment of a host of debilitating and life-threatening medical conditions, biologic drugs often cost on average 22 times more per daily dose than chemical medications, the most expensive of which costs well over $100,000 per year,” Deal said.

The bill also states that if an applicant is the first to establish that its product is interchangeable with the reference product for one or more conditions of use, the government is prevented from approving a subsequent application for an interchangeable version of the reference drug until 180 days from the first commercial marketing or one year after a final court decision.

The bill also prohibits the marketing of a rebranded interchangeable product distributed with the authorization of the reference product holder during the exclusive marketing period.

“I’m pleased to be a part of a commonsense effort at this bipartisan bill to bring generic versions of name-brand biologic medicines to market,” Emerson said. “Across the country, Americans who cannot afford name-brand biologics have been left with no alternatives to their high prices for decades. This bill would create access to affordable generic versions of their prescriptions during an especially difficult economic time for many American families and senior citizens on fixed incomes.”

This bill has support from various groups, including businesses, payers, patient groups, consumer groups, and unions.

It has been endorsed by the Consumers Union, AARP, the National Organization of Rare Disorders, the Coalition for a Competitive Pharmaceutical Market, General Motors, Express Scripts, Inc, and the National Business Group on Health.