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Strengthening the Food and Drug Administration

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STRENGTHENING THE FOOD AND DRUG ADMINISTRATION

The Food and Drug Administration (FDA) is charged with protecting the public health by assuring the safety and security of prescription and over-the-counter medicines, medical devices and many additional products commonly used by all Americans. Recently, the House of Representatives worked in a bipartisan fashion to pass legislation overhauling and strengthening the FDA. This important legislation, the Food and Drug Administration Amendments Act, was signed into law last week by the President and will dramatically improve our country's system for ensuring the safety of our food and drugs by providing the FDA with new resources.

The Food and Drug Administration Amendments Act reauthorizes the critical Prescription Drug User Fee Program and the Medical Device User Fee Program. The fees collected through these important programs are used to finance the FDA's review of applications to market new medicines and medical devices. These programs were set to expire at the end of September so without Congressional action, the FDA would have been forced to lay-off nearly 2000 employees - the very employees who are responsible for reviewing and approving new drugs, biologics, and medical devices. Losing these valuable experts would severely jeopardize the access that patients have to new therapies.

This important legislation also addresses the issue of drug safety. While no drug is completely safe, they do have risks, the FDA is tasked with ensuring that the benefits of a particular drug outweigh any potential side effects or risks. The Food and Drug Administration Amendments Act guarantees that the FDA has the authority to monitor drugs to ensure that both the benefits and risks of new drugs are carefully weighed. The legislation also gives the FDA the authority to require that pharmaceutical companies conduct a post market clinical trial so that drugs that show excessive health risks can be withdrawn quickly. Also, the FDA can now require that drug companies update their labels with new safety information.

Additionally, the legislation tightens the requirements for direct-to-consumer drug advertising. Now all of those television commercials for prescription drugs will be more closely scrutinized by the FDA and the agency will have the authority to impose fines when the ads are false or misleading.

Finally, the Food and Drug Administration Amendments Act creates a public, searchable database of clinical trials for drugs and medical devices. The database will include information on safety risks for both privately and publicly-funded clinical trials. The database will be administered by the National Institutes of Health (NIH) and will be available through the Internet.

The Food and Drug Administration Amendments Act provides the FDA with urgently needed new resources. This important legislation, which I was pleased to support when it overwhelming passed the House of Representatives, will strengthen the FDA's ability to protect consumers and ensures that patients have timely access to life-saving innovations.


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