FDA Drafts New Rules for Testing, Approving Drug Cocktails; Public-Private Partnership for TB Treatment Development Launched

The FDA is drafting new guidelines for testing and approving multidrug cocktails for life-threatening diseases, the Wall Street Journal reports. "Many diseases, such as AIDS, tuberculosis and cancer, require multidrug combinations. Such drug cocktails can prevent the development of drug resistance, because the microbe or cancer cell needs to undergo more mutations to escape several drugs than to escape just one. By attacking the disease in different ways, drug combinations also improve the chances of therapeutic benefit," the newspaper reports (Schoofs, 3/18).

The new guidelines will help "speed up [the] approval of new combination treatments by decades," and "at least 10 companies agreed to work together to test experimental tuberculosis treatments simultaneously in new combinations" as part of a new initiative, BusinessWeek reports (Randall, 3/18).

"Known as the Critical Path to TB Drug Regimens (CPTR), the initiative will test promising combinations of individual TB drug candidates from different companies early in the development pipeline -- and identify the best new treatment regimens," a Global Alliance for TB Drug Development (TB Alliance) press release said. The collaboration of public-private partners was created by TB Alliance, the Critical Path Institute, and the Bill & Melinda Gates Foundation and includes scientists from FDA and pharmaceutical companies (3/18).

Previously, the FDA "required each new drug to be tested and approved individually," the Wall Street Journal writes. To win approval for multidrug regimens required "additional, time-consuming clinical trials. ... Now the FDA is drafting guidelines on how testing and approving multidrug cocktails composed of new, experimental drugs -- something the agency has never done before, according to an FDA spokeswoman," according to the newspaper, which adds that the change "would apply only to medications for life-threatening illnesses for which good treatment options do not already exist, and for which drug combinations -- as opposed to single agents -- are believed to be necessary" (3/18).

"FDA is absolutely committed to working with partners to speed access to new, safe and highly-effective treatments for TB, which continues to mutate and spread," FDA commissioner Margaret Hamburg said in the press release. "This creative approach mirrors FDA's own investments in innovative regulatory science that ensures the best new medical technologies -- including combination therapies -- reach patients as soon as possible."

"This type of collaboration between the public and the private sector is exactly what's needed to help speed the availability of a shorter and more effective treatment for TB," said Tachi Yamada, president of the Global Health Program at the Gates Foundation. "A successful drug combination regimen to fight TB could save millions of lives" (3/18).

"The FDA has really come on board to try to do some out-of-the-box thinking," Ann Ginsberg of the TB Alliance told BusinessWeek. "'In tuberculosis, where the medical need is so urgent and the timelines for development are so long, it just becomes completely impractical to believe you're going to make advances' using standard methods of drug development, she said." Around 1.7 million people die from TB each year, according to the WHO, BusinessWeek reports (3/18).

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