New FDA commissioner Gottlieb unveils price-fighting strategies
During the campaign and since the U.S. presidential election, President Donald Trump has pledged to bring down drug costs and, in some cases, railed against the industry for its pricing. Now, his new FDA commissioner is laying out some approaches the agency will take to fight high prices. Importantly, the FDA can’t regulate drug prices, but it can implement measures aimed at deterring the types of price hikes that have made so many headlines over more than a year. At a U.S. House of Representatives budget hearing on Thursday, new FDA commissioner Scott Gottlieb said his agency will publish and regularly update a list of medications that are off patent and have no competition, work to improve generic review times and seek to “curtail gaming” of regulations by the industry that allows companies to extend patent monopolies. In his opening remarks at the budget hearing, Gottlieb said he’s working on a “drug competition action plan” that he will unveil soon. However, the new commissioner did offer a few strategies to lower costs.
EpicGenetics looks north to expand landmark fibromyalgia study
For four years, EpicGenetics has been selling its diagnostic for fibromyalgia in the U.S. Now it can list Canada among its international markets for the test. The company says approval and launch in Canada will help it push forward with an ambitious R&D program that is trying to decipher the underlying genetic basis for the chronic and painful condition, which affects millions of people worldwide. The Santa Monica, California, company made waves when its FM/a blood test for fibromyalgia secured a CLIA certification and became the first test available for fibromyalgia, which often goes undiagnosed because its symptoms can be so diverse. Aside from pain it can be accompanied by fatigue, sleep disturbances, muscle tenderness, headaches and depression, as well as problems with thinking and memory function.
