WASHINGTON -- Retailers are applauding President Bush's proposal to help speed the path of generic drugs to market.
Retailers and industry sources said that the plan would offer a more economical prescription drug option for consumers, open a more profitable product line for retailers, and help to contain spiraling health care costs.
Bush's proposed rules would prevent drug companies from using legal tactics to stave off competition from generic drugs once patents expire on their products.
"It's a great first step, and we're supportive of this measure. Generic drugs are certainly one of the most economical ways as a nation to maintain out-of-control drug costs," said Curtis Hartin, director, professional services, Schnuck Markets, St. Louis.
The proposal's impact on retailers would be significant, he noted.
"Certainly, any time a major product loses its patent, it has a tremendous impact at store level. It allows for greater access; it becomes more profitable for us and more affordable for customers," Hartin said. Generic drugs generate a large piece of sales revenue for Schnuck pharmacies, he said.
Bob Passavanti, director, pharmacy operations, Coborn's, St. Cloud, Minn., also supported the Bush proposal. "I think it's great," he said. "Hopefully, we'll be able to buy drugs cheaper."
Upon announcement of the proposal recently, President Bush said, "Our message to brand-name manufacturers is clear: You deserve the fair rewards of your research and development. You do not have the right to keep generic drugs off the market for frivolous reasons."
The White House plan would implement the recommendations of a 2002 report by the Federal Trade Commission. It would have the U.S. Food and Drug Administration issue a new rule that would close a number of loopholes that currently permit pharmaceutical companies to delay the introduction of generic drugs. The proposal would limit drug makers to one 30-month stay per generic application to resolve allegations that a generic drug maker is infringing a patent; tighten requirements and increase disclosures for drug patent listing; and require manufacturers to submit more detailed and signed confirmations accompanying patent submissions.
President Bush's proposal is similar to legislation proposed by the House (H.R. 5311 and H.R. 5272) and Senate (S. 812) earlier this year. This new legislation would save consumers $6 billion a year, according to the Congressional Budget Office.
After the 60-day comment period, the FDA will review all response documents. Should the administration approve any changes, the FDA will submit the revised document as a final rule.