FDA Proposes Wider Access to Experimental Drugs
WASHINGTON (Reuters Life) Dec 11 - Drug companies could soon make more experimental drugs available for a fee to more patients with serious or life-threatening diseases that have no approved treatments, under revised rules the U.S. Food and Drug Administration proposed on Monday.
Manufacturers would be allowed to charge consumers enough to cover costs directly linked to drug development as well as administrative costs to make the products available, the FDA said.
"By clarifying and streamlining the processes, FDA also hopes to encourage companies to make such drugs available, and reduce barriers for health-care practitioners in obtaining them," Dr. Janet Woodcock, FDA's deputy commissioner for operations, said in a statement.
Such experimental drugs, which have not yet been approved by the agency, have been available to some patients under certain circumstances since the 1970s.
In the past, the FDA has allowed thousands of patients with HIV or AIDS, cancer and heart problems to use drugs before they were approved.
But agency officials said the current regulations caused confusion by not clearly stating when companies could charge a fee.
The new rules spell out access for individuals as well as small groups of patients, the FDA said. It also clarifies how companies should calculate their fees.
FDA's proposal comes amid legal wrangling over access to unapproved therapies.
In May, the U.S. Court of Appeals for the District of Columbia sided with two advocacy groups that sued the FDA seeking patient access to new cancer drugs that were shown to be safe in initial tests but had not yet received approval.
The case was sent back to lower courts for review.
The public has 90 days to comment on the proposed changes and can submit comments on the FDA's Web site at (
http://www.fda.gov/dockets/ecomments).
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