Jones Introduces the Early Access to Treatment Act

Press Release

JONES INTRODUCES THE EARLY ACCESS TO TREATMENT ACT

Third District Representative Walter B. Jones (R-NC) recently introduced H. R. 6047, the Early Access to Treatment Act. The legislation would amend the Federal Food, Drug, and Cosmetic Act to mandate early access for patients to new drugs under clinical investigation for serious or life-threatening conditions when there are no comparable or satisfactory drugs available.

"Unfortunately, many Americans face serious or terminal diseases and currently cannot access investigational drugs that are caught up in the Food and Drug Administration's (FDA) review process," Congressman Jones said. "According to the Congressional Research Service, the drug approval process takes an average of 15 years from the moment a manufacturer first approaches the FDA with an idea for a new drug to its final approval for marketing. Many times, these drugs are approved only after a patient has been severely diminished by disease or has already died."

"While the clinical trial process contributes to the safe distribution of these life-saving drugs, it does not include every seriously or terminally ill patient," Jones said. "Many patients are left out of the clinical trial process and, as a result, cannot access the drugs they desperately need. This legislation would help alleviate this problem."

H.R. 6047, the Early Access to Treatment Act, would:

- mandate early access for patients to new drugs under clinical investigation for serious or life-threatening conditions when there are no comparable or satisfactory drugs available;

- allow patients to work with a licensed practitioner to determine individual patient suitability to apply for a particular investigational drug; and

- give patients, licensed practitioners, and drug providers the freedom to negotiate all liability issues by contract.

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