DRUGS/FDA/SCOTT GOTTLIEB: “The new commissioner of the Food and Drug Administration declared high drug prices are ‘a public health concern that FDA should address,’ and he began offering concrete steps the agency will employ to speed new, complex drugs to market through more efficient processes partially designed to address high drug prices.
Commissioner Scott Gottlieb is focusing first on what he terms ‘complex generics.’ The move to speed the regulatory approval process for drugs in this fast-growing area of the drug market would help introduce competition that might act to slow drug price increases, or even lower prices…
Dr. Gottlieb’s move is largely unprecedented for an FDA commissioner. The FDA has traditionally taken the position that the agency’s sole role in medical-product approval is assessing safety and effectiveness, and that pricing is generally out of its purview. Pricing for some particularly important, high-price drugs, such as those used for cancer and hepatitis, remain beyond the FDA’s reach.
Yet, in Monday’s blog post, Dr. Gottlieb appears to be trying to address high drug prices. Dr. Gottlieb said that in the case of chemically complex drugs, such as the multiple-sclerosis drug glatiramer acetate injection or drug-device combinations, the agency will be taking steps like publishing a guidance to manufacturers on how to make early meetings with the agency more scientifically efficient.”
-Thomas M. Burton, “FDA Chief Says High Drug Prices ‘Public Health Concern’ Agency Should Address,” The Wall Street Journal online, Oct. 2, 2017 11:20am