On a vote of 385-41, the U.S. House voted Thursday to pass the U.S.-Mexico-Canada Trade Agreement (USMCA). To help get House Democrats on board with the pact, the Trump administration agreed to drop a provision calling for a 10-year exclusivity for biologics. While two years shorter than the 12 years’ exclusivity currently offered in the U.S., a 10-year period would have doubled the protection innovative biologics have in Mexico and add two years to the protection awarded in Canada. By removing the exclusivity provision from the agreement, the Trump administration “surrendered one of the most important tools that would help stop” foreign free-riding on American medical innovation, said Jim Greenwood, president and CEO of the Biotechnology Innovation Organization. Stephen Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, echoed that concern. “Eliminating the biologics provision in the USMCA removes vital protections for innovators while doing nothing to help U.S. patients afford their medicines or access future treatments and cures,” Ubl said. “The only winners today are foreign governments who want to steal American intellectual property … and free ride on America’s global leadership in biopharmaceutical research and development.” The Senate is expected to vote on the agreement next year.
The FDA is requiring new warnings about the risk of respiratory depression to be added to the prescribing information of gabapentinoids, including gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR). The agency found that gabapentinoids are often being combined with central nervous system depressants – such as opioids, anti-anxiety drugs, antidepressants and antihistamines – which increases the risk of respiratory depression. Subsequently, the FDA is requiring gabapentinoid manufacturers to conduct clinical trials to further evaluate their abuse potential, particularly in combination with opioids. Misuse and abuse of opioids and gabapentinoids together is increasing, the FDA said.
The FDA test-drove a pilot format for its briefing document this week for the Oncologic Drugs Advisory Committee’s consideration of a new indication for Merck & Co. Inc.’s Keytruda (pembrolizumab). Rather than having the agency and Merck each prepare separate documents that are sent to committee members in advance of the meeting, the FDA compiled the comments into one document, following a point-counterpoint format. Agency officials explained that the intent behind the pilot was to reduce the redundancy and keep important data from getting lost in the volume of information panelists usually receive. While committee members welcomed the new format for its clarity, they noted there was no quality of life information. Several members recommended that the FDA include that information in an appendix.
Framing it as a complement to the 1998 guidance “Providing clinical evidence of effectiveness for human drug and biological products," the FDA this week issued a draft guidance, “Demonstrating substantial evidence of effectiveness for human drug and biological products.” While the agency’s evidentiary standard for effectiveness hasn’t changed since 1998, “the evolution of drug development and science has led to changes in the types of drug development programs submitted to the agency,” according to a notice in Friday’s Federal Register. For instance, the FDA noted an increase in drug development programs focusing on serious diseases lacking effective treatment, rare diseases and disease subsets. Thus, more guidance is needed on the flexibility in the amount and type of evidence that’s necessary to meet the substantial evidence standard in such circumstances, the agency said. Comments on the draft should be submitted by Feb. 18.