H.R. 1561:The Enhancing Drug Safety and Innovation Act of 2007

Written by on Thursday, March 22nd, 2007

H.R. 1561:The Enhancing Drug Safety and Innovation Act of 2007 was introduced this week by Representative Henry Waxman (D-CA) and Representative Edward J. Markey (D-MA).   H.R. 1561 is the House counterpart to the Enzi-Kennedy drug safety bill (S. 484). Representative Waxman’s website states that H.R. 1561 will do the following:

  • Give the FDA enhanced tools to ensure post-market drug safety through the “Risk Evaluation and Mitigation Strategy” (REMS) process, including: (1) increasing the possible moratorium on direct-to-consumer advertising from two years to three years; (2) adopting the IOM recommendation that the FDA place a symbol on the packaging of a product to let consumers know that the drug is new to the marketplace; and (3) requiring a review of drug products after they have been on the market for 7 years (the average time it takes to detect most side effects);
  • Increase the transparency of the REMS review process;
  • Enhance FDA’s enforcement authority by giving the FDA the ability to impose civil monetary penalties if drug companies fail to comply with any requirements relating to drugs in the Federal Food, Drug, and Cosmetic Act and increasing the amount of those civil penalties;
  • Provide for a balance between funding from user fees and federal dollars in FDA’s drug safety budget by authorizing $25 million for each of fiscal years 2008 through 2012 in addition to other funds available for carrying out Title I activities;
  • Require the FDA to report to Congress on its efforts to integrate the expertise of the Office of Surveillance and Epidemiology (formerly Office of Drug Safety) into the Agency’s approval, labeling, and post-approval safety decisions; and
  • Strengthen the clinical trials registry and results databases to include more information on more trials (including medical devices), and give the Secretary the added ability to impose civil monetary penalties for non-compliance.

The Scientist reported on the Senate version of this bill in August, 2006, highlighting two opposing viewpoints on the proposed legislation.

The biotech industry has been somewhat silent as to the pros and cons of this bill to date, which may speak to the industry’s views on the issue–clearly there are times when silence speaks more loudly than words. 

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