WASHINGTON (AP) – Two new AIDS drugs, each of which combines two medications within a single tablet, have been approved by federal regulators, the Food and Drug Administration’s acting commissioner said Monday.

The drugs give AIDS sufferers in poor countries a better chance of survival. It received a speedier review to ensure that safe and effective drugs are made available under the government’s $15 billion emergency plan for AIDS relief.

The FDA approval primarily benefits American consumers. By passing FDA muster, however, the drugs now can be bought by the global AIDS coordinator’s office for distribution to AIDS patients in poor countries.

Components of the new drugs had already been on the market as individual drugs. With the combinations, AIDS sufferers will be able to take a single pill per day instead of two, which experts say is especially pertinent in countries where patients are likely to have less experience with medical routine.

“It is our firm belief that these steps will make a huge difference in the lives of millions of people in Africa, Asia and the Caribbean … by assuring that the drugs they get under this program, indeed, will be quality products,” acting FDA Commissioner Lester M. Crawford told a luncheon crowd at the National Press Club.

The World Health Organization estimates that only 400,000 of the 6 million people worldwide who need AIDS treatment receive combination drugs that could extend their lives.

Gilead Science’s Truvada, to be distributed in developing nations in a lighter shade of blue than in the United States, reduces virus that circulates in the body and boosts the number of cells that attack the virus that causes AIDS.

The manufacturer of the second drug, GlaxoSmithKline, said it will issue vouchers providing free 60-day supplies of Epzicom directly to patients in the United States. The vouchers, in limited supply and issued by health-care providers, target patients who haven’t used anti-retroviral therapy before or need their therapies changed.

Crawford announced the new drug approvals in outlining the agency’s to-do list for the next six months.

Besides other initiatives, the agency aims to:

-Hammer home the need for best manufacturing practices to reduce risk for consumers. “It is impossible to inspect every prescription drug pill, every diagnostic testing kit, every animal vaccine and every food parcel that is manufactured,” Crawford said.

-Complete guidelines for companies that make supplements, preventing products with impurities or contamination from reaching consumers.

-Let patients with serious and terminal ailments to receive promising drugs that haven’t yet gotten final agency approval.

-Finish orders companies to make wording on prescription drug labels less complicated so users can understand what the pills they’re swallowing do.

-Prevent salmonella infection, which kills 87 and sickens 213,000 each year, by reducing the risk posed by contact with tainted eggs.

-Demystify carbohydrates by spelling out what is or is not low-carb. “It’s hard to imagine carbohydrates are mysterious,” Crawford said, adding that some manufacturers’ labels make them so.



On the Net:

Food and Drug Administration: http://www.fda.gov

Gilead Sciences: http://www.gilead.com/wt/home

GlaxoSmithKline: http://www.glaxo.com

AP-ES-08-02-04 1912EDT



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