PHRMA CEO: PATENT LAW CHANGES, IMPORTATION COULD HARM INDUSTRY

The pharmaceutical industry must fight potential legislation that could harm it, PhRMA CEO Billy Tauzin said. Changes to patent laws, Medicare and drug importation laws could damage the industry's reputation and harm public safety, Tauzin added, speaking at PhRMA's annual meeting March 16.

Tauzin focused on S.242, the "Pharmaceutical Market Access and Drug Safety Act of 2007," which would allow U.S. citizens to import drugs from FDA-approved Canadian facilities at lower prices. Tauzin previously criticized the legislation at a recent Senate committee hearing.

"Many [Americans] would die directly as a result of this legislation," Tauzin said at the meeting. Allowing drugs to be imported opens the door to "an epidemic" of counterfeit products that could be ineffective or dangerous to patients, Tauzin added. The public's trust in the safety of drugs in America would be lost and "near impossible to retrieve," he said.

The bill's sponsors say it covers all possible safety issues, requiring 12 FDA inspections of the facilities each year as well as a pedigree system to track the imported products.

Tauzin also said Congress should leave Medicare alone because it is working and seniors are happy with its programs. Before attempting to change Medicare, lawmakers should consult PhRMA and work with the group to improve the programs, Tauzin said.

In addition, lawmakers need to consider how changing patent rules will affect drug companies' R&D efforts, Tauzin said. Shortened patents on drugs could severely hinder companies' abilities and resources to create new drugs because new products take so much time to develop, he added.

( http://www.fdanews.com/did/6_55/ )