Let's give the FDA the oversight power it needs to protect patients.

The U.S. Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicines and other health products. But there are some dangerous gaps in the oversight powers the FDA needs. That puts us all at risk.

Congress needs to give the FDA three important new tools to do its job more effectively.

Drug safety: Make companies complete post-approval clinical trials that confirm the drug's predicted benefit, or remove the drugs from the market if not.

Dietary supplements: Require manufacturers to provide lists of their products and ingredients before putting these supplements on store shelves.

Diagnostic testing: Ensure medical tests give accurate results and won't harm the patients that use them.

Subject: Give FDA the tools it needs to protect patients from unsafe medicines, tests and dietary supplements.

Your Letter:

Tens of thousands of drugs, supplements and diagnostic tests are being used across the country without full FDA approval or review.

Please pass needed reforms to close the gaps in FDA oversight. There are three important tools that the FDA needs to keep patients safe.

* The FDA needs authority to make companies complete post-approval clinical trials that confirm the drug's predicted benefit, or remove the drugs from the market if not. To get certain life-saving drugs to patients swiftly, the FDA can give "accelerated approval" to certain medicines even before full clinical trials are completed. But that approval is contingent on finishing the drug testing to prove the medicine delivers the promised health outcomes. Nearly half (112) of the 253 "accelerated approval" drugs have not been confirmed as clinically effective.

* The FDA needs the ability to require all dietary supplement manufacturers to submit basic information to the FDA -- including the product name and a list of ingredients -- before marketing the products to consumers. Families spend over $40 billion dollars every year on vitamins, minerals and herbal products that we hope will help us stay strong and healthy. Yet, the FDA has no way to track the 80,000 vitamins, minerals and herbal products and doesn't even know what these supplements contain.

* The FDA needs oversight powers to ensure that these medical tests give accurate results and won't harm patients that use them. Patients and doctors should be able to trust that diagnostic tests, such as genetic or blood testing, are safe to use and that tests accurately detect or measure what they seek to measure. But certain lab-developed tests that doctors use to identify illnesses and medical conditions are not reviewed by the FDA.

Thank you for making patient safety a priority and giving the FDA the tools it needs.

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