Issue Date: October 9, 2017
FDA acts to expand access to complex generic drugs
FDA will take steps to increase the availability of certain lower-cost generic medicines in an attempt to address the rising cost of prescription drugs, the agency’s head said last week. The agency will expedite the approval process for generic alternatives to hard-to-make complex drugs, FDA Commissioner Scott Gottlieb said in a blog post. “Any steps we can take to encourage the development of generic competitors to complex drugs will have an outsized impact on access, and prices,” Gottlieb said. “If consumers are priced out of the drugs they need, that’s a public health concern that FDA should address.” The new policy is significant because the agency has historically made its decisions on the basis of safety and efficacy without regard to cost. Complex drugs include medicines like metered-dose inhalers to treat asthma that have at least one feature that is difficult to replicate under current rules. To help get more generic versions of these drugs on the market, FDA will provide companies with guidance on how to win approvals, including offering meetings with agency staff early in the process.
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