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FDA Weighing Non-Prescription Status for Chronic Disease Drugs

The Food and Drug Administration is weighing whether to let consumers buy medicines for some chronic conditions without a prescription while speeding approvals of drugs for infection, Alzheimer’s disease and rare conditions.

FDA Commissioner Margaret Hamburg and the agency’s director of the Center for Drug Evaluation and Research yesterday outlined ways to get drugs in patients’ hands faster. The House Energy and Commerce health subcommittee today will hold a hearing on ways to expand the agency’s accelerated approval program and encourage drugmakers to develop antibiotics.

The FDA plans to expand its accelerated approval program based on relaxed standards for effectiveness, which is now largely limited to AIDS and cancer drugs, said Janet Woodcock, the agency’s top drug evaluator. The agency will also hold a two-day public meeting this month to evaluate whether to reclassify drugs for high blood pressure, cholesterol, migraines and asthma so patients can get them without a prescription.

“This is obviously a time when there is a lot of discussion about different kinds of strategies and approaches and we want to participate in those discussions and provide the kind of expertise and perspective the team has to offer,” Hamburg said. “Particularly, as the science is unfolding in new and exciting ways that will give us new tools, I think we are in a position to do things differently than we have historically.”

The accelerated approval system, which requires further testing after products are on the market, would benefit treatments for rare diseases and Alzheimer’s, Hamburg and Woodcock said.

Congressional Republicans have criticized the agency for squelching innovation with last-minute requests for more safety information and conflict-of-interest rules that discourage scientists from sitting on advisory panels.

Without Prescription Proposal

The proposal to make some prescription medicines available over the counter could help reduce medical spending by reducing doctor visits and the amount insurers pay on pharmaceuticals, said Robert Goldberg, vice president of the Center for Medicine in the Public Interest in New York.

“There’s a convergence of interests here,” Goldberg said. “Health plans would love to see this happen. It means people won’t go to the doctor as much for stuff.”

Pharmacists can help patients assess their conditions with the aid of digital tools and kiosks.

Cholesterol and blood pressure medicines shouldn’t be made available without a prescription, said Sidney Wolfe, director of health research for the consumer group Public Citizen in Washington. Reclassification should only occur if patients can diagnose their illnesses themselves and the medicine doesn’t require a physician’s supervision, he said by phone.

Speeding Antibiotics

The FDA also wants to allow makers of antibiotics to test the drugs on smaller groups of patients. Woodcock said she envisions labels for such products that would keep doctors and hospitals from overprescribing the treatments, limiting their use to help combat antibiotic resistance.

“It basically has reached crisis proportions,” Woodcock said.

The FDA is weighing a similar label for obesity drugs as well to limit overprescribing, she said.

Lawmakers have proposals that also would expand the accelerated approval program and give drugmakers incentives to develop new antibiotics. Woodcock and Hamburg said they’re working with Congress and didn’t endorse either bill.

The agency can use its administrative powers to make many of the changes, though it might need clarifying language on accelerated approvals, Hamburg said.

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