Woodcock Defends FDA as Experts Question Agency Regarding Antibiotics

Source: PharmaManufacturing.com

Jun 11, 2010

Reuters

By Julie Steenhuysen

CHICAGO (Reuters) -- U.S. regulators need to provide a clear path for drug companies to develop new antibiotics and should consider offering financial incentives, experts told a Congressional panel on Wednesday.

They said doctors are running out of effective antibiotics, yet inconsistent regulatory guidelines at the U.S. Food and Drug Administration and the need to reduce the use of antibiotics has given companies little incentive to develop new drugs, experts told the House of Representatives Committee on Energy and Commerce's Subcommittee on Health.

Several experts acknowledged the need for more judicious use of existing antibiotics to slow the rise of antibiotic resistant strains of bacteria, but virtually all agreed that several routes are needed to solve the problem.

Robin Robinson, director of the Biomedical Advanced Research and Development Authority at the Department of Health and Human Services, called antibiotic resistance a biodefense threat and said the federal government should provide financial incentives to encourage companies to develop new antibiotics.

He said his agency is supporting the development of new dual-purpose antibiotics that could be used to improve both public health and national security.

"The lengthy drug development process means that new classes of drugs to supplement or replace current ones are still years away at best," Robinson told the panel.

He noted that newer drugs are typically saved for the sickest patients, reducing their sales potential.

Longer Patents?


Dr. Barry Eisenstein, a senior vice president at Cubist Pharmaceuticals, has one answer for this -- extending the time patent protections are in place.

"We are approaching a "crisis point" with antimicrobial resistance," Eisenstein told the panel.

He complained that the FDA has been inconsistent in what it requires drug companies to prove to win marketing approval.

"Over the last decade, regulatory uncertainty, including ever-shifting FDA guidelines, have had a significant negative impact on approval of antibiotics," he added.

Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, agreed that more needs to be done to encourage drug companies to develop new antibiotics.

"The pipeline is diminished at a time when the need could not be greater," she said.

But she said scientists have disagreed over what the bar should be for proving an antibiotic works as well or better than existing drugs, especially for the treatment of common conditions like sinus infections or ear infections.

Approving an inferior drug that would be so widely used would only contribute to the problem of antibiotic resistance, she said.

"FDA plans to publish additional guidance on these methods within the next six months to establish new standards for antimicrobial drugs," Woodcock said.

Almost as soon as penicillin was introduced in the 1940s, bacteria began to develop resistance to its effects, prompting researchers to develop many new generations of antibiotics.

But their overuse and misuse have helped fuel the rise of drug-resistant "superbugs." The U.S. Centers for Disease Control and Prevention says most infections that people get while in the hospital are resistant to at least one antibiotic.

For example, half of all S. aureus infections in the United States are resistant to penicillin, methicillin, tetracycline and erythromycin.
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