In another move to bring down U.S. drug prices, a bill was introduced last week in both the House and Senate to shrink the exclusivity for biologics from 12 years to seven years. Rep. Jan Schakowsky (D-Ill.) and Sens. Sherrod Brown (D-Ohio) and John McCain (R-Az.) said the Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act would save billions of dollars over the next 10 years by fostering biologic competition and allowing earlier launches of biosimilars. Using Gleevec (imatinib, Novartis AG) as an example of why the legislation is needed, Schakowsky pointed out that the cancer drug came to market at a list cost of $26,400 in 2001, but its annual list price today is $120,000. The 12-year-exclusivity for biologics was written into law as part of the Affordable Care Act in 2010; President Barack Obama has unsuccessfully pushed to have it reduced in every budget since then. While drug prices are currently a hot issue, getting the PRICED Act through Congress this year could be challenging given the tight schedule before the November election, which will be followed by a lame duck session. So far, the House version of the bill has no Republican sponsors. Delays in biosimilars coming to market to date have been due to patents, regulatory issues and court interpretations of provisions in the Biologics Price Competition and Innovation Act – not exclusivity.
The FDA is extending the comment period for two draft guidances because of next week’s scheduled maintenance on the Federal Erulemaking portal. The extensions apply to draft guidances on special protocol assessments and the development of direct-acting antiviral drugs to treat hepatitis C infections. Both drafts were published in the Federal Register May 4. Comments are now due by July 19.
The FDA issued a technical specifications document “Quality Metrics Technical Conformance Guide, Version 1.0,” as a supplement to the draft guidance “Request for Quality Metrics” that it released for comment a year ago, even though that guidance has yet to be finalized. The agency said it issued the new specifications document to provide clear expectations on the submission of quality metric data for drugs. Comments on the guide are due by Sept. 25.