White House urges more generic biologics debate

Last Updated: 2007-05-02 10:16:54 -0400 (Reuters Health)

WASHINGTON (Reuters) - The Bush administration said on Tuesday it opposed any attempt to add legislation on generic, or "follow-on," versions of biologic drugs to a Food and Drug Administration bill being debated in the U.S. Senate.

Biologics, made from proteins derived from living things, cost thousands of dollars a year. Makers say the medicines are more complex than chemical-based drugs and difficult to copy.

But generic drugmakers say they can produce cheaper copies, and are urging Congress to set a clear path for FDA approval.

"The administration believes further discussion must take place before addressing these issues in legislation. The administration strongly opposes the inclusion in this bill of any provision related to follow-on (biologic) products," a statement said.

Some Senate supporters have wanted to add generic biologics legislation to the FDA bill, which would extend industry fees for drug and medical device reviews and give the agency new powers to police side effects.

Any measure on generic biologics "must, as a first priority, ensure the safety and efficacy of the resulting products" and "should also include adequate intellectual property protections" for companies that develop the brand-name versions, the Republican administration said.

The bill's authors, Massachusetts Democrat Edward Kennedy and Wyoming Republican Mike Enzi, said staff were working behind the scenes on possible amendments. They did not provide details.

Other senators said they planned to try to add measures to strengthen food safety oversight and allow imports of cheaper medicines.

The Bush administration said it would oppose any importation measure that did not address concerns that drugs bought from other countries could be dangerous.

If such an import provision were added, "the president's senior advisers would recommend that he veto the bill," the administration statement said.

The White House repeated earlier concerns that some of the new drug safety measures in the legislation would be burdensome without helping to improve FDA oversight.

Also, cutting incentives for drugmakers to study drugs in children would reduce the effectiveness of the program, the administration said. The Senate bill would limit the extra patent protection awarded for pediatric studies to three months for drugs with more than $1 billion in annual sales. Other drugs could still receive six months.