New FDA scrutiny for old drugs

(FSB Magazine) -- In the shadow of behemoths such as Pfizer, hundreds of small companies make thousands of long-established drugs that the majors no longer bother with. Now the U.S. Food and Drug Administration is stepping up a campaign to put these medications through its costly new-drug approval process. And that could place the little guys in peril. Deborah Autor, director of the FDA's office of compliance, says the agency is promoting consumer safety. "People think drugs are safe because they have been around, but they aren't," she says.

Little companies say the policy has a deadly side effect - preventing them from selling drugs that have been proved safe and effective. Blansett Pharmacal (blansett.com) in Little Rock is one of 70 companies that the FDA has ordered to stop selling timed-release preparations of the expectorant guaifenesin, starting in November.

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It's not because of danger to patients (Autor confirms that the pills, sold since the 1950s, pose no known safety issues, but she says the FDA is concerned about the manufacturing process). Blansett's product and others like it are outlawed simply because Adams Respiratory Therapeutics (adamsrt.com), a $332-million-a-year drugmaker in Chester, N.J., spent millions to win FDA approval for its pill Mucinex. That renders the others unapproved.

The Branded Pharmaceutical Association (brandedpharmaceutical.com), a group based in Birmingham, Ala., representing small drugmakers, is fighting the FDA. "Adams got an immediate monopoly," says BPA president Perry Cole. Larry Blansett, CEO of Blansett Pharmacal, says a basic timed-release guaifenesin used to go for as little as 6 cents a pill. Adams, which raised prices a year ago, says retail prices for Mucinex range from 45 cents to 60 cents.