FDA could Speed Approval Process for Certain Drugs

Obesity treatments, life-saving antibiotics and other drugs deemed to offer societal benefit despite their risks may get speedier U.S. approvals under plans being discussed to better balance innovation and safety.

Food and Drug Administration Commissioner Margaret Hamburg told scientific advisers the agency is considering letting makers of such treatments conduct faster clinical trials with a smaller group of patients than now required. A “special medical use” label could be used, allowing doctors to administer the drugs to patients in most dire need, she said.

“This is an issue of having the right science and data to assess risks and benefits but also a broader societal discussion about risks and benefits that individuals and communities are willing to take on and under what circumstances,” Hamburg said in a recording of a meeting released by her agency.

Arena Pharmaceuticals Inc. (ARNA)’s Belviq weight-loss pill and Vivus Inc. (VVUS)’s Qsymia may have been approved earlier for use by morbidly obese people had such a path existed. The FDA at first rejected both drugs in 2010 because of safety risks that took the companies another two years of research to justify. The FDA needs to better account for the needs of patients with deadly or debilitating diseases who may be willing to accept the additional perils of unproven drugs, Hamburg said.

“A pathway that would allow products to come to market faster but would ensure they were used only in patients where there was an applicable risk-benefit situation would be good,” said Allan Coukell, deputy director of medical programs for the Pew Health Group in Washington, who has been involved in the FDA discussions. “It would be good for developers, for companies and it would be good for public health.”

Infectious Diseases

Details are still being worked out, Coukell said in a telephone interview. How much evidence would be required and how does a company generate the data to expand a limited approval later are still unknown, he said.

The accelerated pathway might be used for drugs to treat infectious diseases, antibiotics to combat drug-resistant bacteria and weight-loss treatments, Hamburg said at the Oct. 3 meeting with advisers without identifying any specific medicines. Drugmakers may have a chance to prove the benefits outweigh the risks, removing the restrictive designation and allowing sales to a broader population, Hamburg said.

Scientific advisers to President Barack Obama had also discussed the approach in a report last month as a way to propel drug innovation.

Obesity Pills

The FDA first brought the idea up during debate earlier this year over reauthorization of fee programs that fund new drug and medical-device reviews, said Karen Riley, an FDA spokeswoman. One more program that funds animal drug reviews must be reauthorized next year and would open a window to create the special medical use pathway.

The Pharmaceutical Research and Manufacturers of America, the Washington-based lobby group for Pfizer Inc. (PFE), Merck & Co. (MRK) and other drugmakers, wouldn’t comment. When the report from the president’s advisers came out, the organization said it would work with the administration to explore ideas in the report.

Arena’s Belviq became in June the first obesity pill approved in 13 years, followed less than a month later by Qsymia. Vivus’s Qsymia will carry a warning on its label about the possibility the drug may increase heart rates, while Arena and partner Eisai Co., which is licensed to sell Belviq in the U.S., agreed to conduct six post-market studies, including a long-term cardiovascular outcomes trial.

Belviq and Qsymia are still restricted to those who are obese or more than 59 pounds overweight and have at least another condition such as high blood pressure or diabetes yet each company had to conduct clinical trials in at least a few thousand patients. Doctors can use the drugs off-label in patients who want to lose less weight.

Orexigen Therapeutics Inc. (OREX) is developing a weight-loss pill called Contrave with Osaka, Japan-based Takeda Pharmaceutical Co. (4502) Orexigen, based in La Jolla, California, agreed a year ago to conduct a two-year study of the medicine’s heart risks.

Fuente: BloombergBusinessweek