FDA Reform Bill Introduced In House

Republican Representative Ron Wyden has introduced legislation reforming the US Food and Drug Administration, which he said would both ensure drug safety and reduce costs and time in getting new products onto the market.

He said his legislation would keep the FDA's mission intact, and reduce the time and costs of getting life-saving products to the public by providing faster and less expensive approvals, and channeling federal funds into the most crucial safety issues. The bill would allow third-party testing of certain drugs and devices, fast-track approval for innovative drugs and devices, and a relaxation of FDA restrictions on exporting US-manufactured products that are approved by importing countries.

The FDA has already proposed some of the reforms in the Wyden legislation. The Pharmaceutical Research & manufacturers of America told the Marketletter that it welcomes any discussions that would speed-up getting new drug treatments to patients, and that it hopes to have its own suggestions for FDA reform completed this month.