The United States is proposing a fast-track system to provide safe, effective AIDS drugs to poor countries under President Bush’s $15 billion AIDS relief plan, U.S. health regulators said on Sunday.
Guidelines by the U.S. Food and Drug Administration will be issued this week and involve a rapid review process to ensure quality of drugs purchased by the United States for developing countries. The system will also give pharmaceutical groups incentives to develop less expensive AIDS drugs, the Health and Human Services Department said in a statement.
“We are clearing the way to quickly deliver quality, life-saving HIV/AIDS drugs to people who desperately need them in developing countries,” HHS Secretary Tommy Thompson said.
The process will make AIDS treatments easier and cheaper for patients in the developing world.
Controlling HIV/AIDS usually requires taking several different drugs simultaneously. However, the HHS said combination drugs would bring together the different drugs into a single medication.
“Fixed-dose combination products and co-packaged products are an important tool in improving the quality of health care in developing nations,” Thompson added.
U.S. Global AIDS Coordinator Randall Tobias said drug patent issues that apply in developed nations should not impede purchase of these drugs for developing nations.
“The president has made clear that his goal is to put effective treatment into the hands of those who need it in the hardest-hit developing nations and to provide these life-saving services as widely as possible,” Tobias said.
“With FDA review, we will have a gold-standard assurance that a combination product will be safe and effective,” he said.
The review would be open for both brand-name and non brand-name fixed dose and co-packaged drugs, the HHS said.
Thompson said under the proposal, approval of permits could happen within two to six weeks after applications have been received.
For companies making products for which another firm owns the U.S. patent rights, the FDA would issue a tentative approval if the product meets the agency’s standards.
A senior FDA official said the regulator was also looking into whether it could waive or reduce user fees for the AIDS drugs to be reviewed. User fees are normally charged to companies making new drugs.
In reaction, the Elizabeth Glaser Pediatric AIDS Foundation, which provides AIDS treatment services in Africa and elsewhere, said Sunday’s announcement was “a tremendous leap forward.”
It said there should be a sense of urgency about implementing the new system, both on the part of the administration and manufacturers.
“All manufacturers, and especially those that produce generics, must act rapidly to apply for approval of their medications so that they are available for purchase under the President’s Emergency Plan for AIDS Relief and so that we can be certain of the safety and efficacy of the drugs provided,” it said.
Revision date: July 5, 2011
Last revised: by Sebastian Scheller, MD, ScD