The Bush administration announced a new initiative to speed up the approval process for new combination AIDS drugs that will bring cheap, easy-to-use treatment to millions of people in Africa and the Caribbean.
The announcement Sunday came as three major U.S. pharmaceutical companies said they’ll work to develop an AIDS drug offering a single daily dose.
In a joint statement, Bristol-Myers Squibb Co., Gilead Sciences Inc. and Merck & Co. Inc., said they will pursue research to combine three of their HIV medicines into a single tablet.
New guidelines proposed
In Geneva, U.S. Health and Human Services Secretary Tommy Thompson said the Food and Drug Administration will propose new guidelines to ease the approval process for products which combine several expensive treatments already approved individually by the FDA. Patients in developing countries would then have easier access to the treatments.
The decision marks a significant change in U.S. policy, which had been in favor of more stringent standards for such “fixed-dose combinations,” made by foreign companies which manufacture low-cost generic versions of anti-HIV drugs and combine them into single pills.
AIDS advocacy groups and some members of the U.S. Congress have criticized that policy as a front intended to ensure the sales of more expensive patented drugs, delaying if not blocking lifesaving treatments in regions hit hardest by the epidemic.
Globally, the disease affects about 40 million people, with nearly 30 million of them in Africa.
WHO has signaled which combinations are appropriate for use in its international push to get lower-cost HIV treatments to developing countries. The combination pills eliminate the need for patients to swallow multiple pills in treatment cocktails.
Both brand-name manufacturers and foreign generic makers can apply under the new guidelines. FDA approval for the foreign generics would not allow their sale in the United States because of patent laws, but would allow purchases for distribution in developing countries.
“The new expedited process provides us with a solid foundation for purchasing drugs that work,” said Randall Tobias, coordinator of the Bush administration’s activities to combat AIDS. “With FDA review, we will have a gold-standard assurance that a combination product will be safe and effective.”
The pharmaceutical companies said they would include two Gilead drugs, Viread and Emtriva, along with efavirenz, which is marketed by New York-based Bristol-Mysers Squibb as Sustiva and by Whitehouse Station, N.J.-based Merck as Stocrin.
In March, Foster City, Calif.-based Gilead filed regulatory applications in the United States and Europe for approval of a single-tablet fixed-dose combination of Viread and Emtriva.
The companies plan to seek regulatory review and approval of the three-drug fixed-dose combination. The companies also are exploring a co-packaged version that would include the three products as an interim step until a fixed-dose combination product could be made available.
Also Sunday, Britain’s GlaxoSmithKline PLC and German-based Boehringer Ingelheim Corp. said they would begin exploring a co-packaging deal for their AIDS drugs.
Thompson was announcing a review of President Bush’s $15 billion emergency plan for AIDS relief — announced in Bush’s January 2003 State of the Union address — to ensure that the United States is providing safe and effective drugs to 14 of the worst affected countries, 12 of which are in Africa and two in the Caribbean.