Finally, the U.S. Food and Drug Administration gave its long overdue approval of the drug Erbitux, from Imclone Systems, for patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN).

This news serves as yet another reminder that the biggest "Imclone scandal" of 2001 had nothing to do with Martha Stewart, but instead resulted from the FDA's failure to approve a drug that had been proven safe and effective for thousands of patients. More than four years have passed since that tragic decision in December of 2001, a rejection based on technical issues in the application unrelated to Erbitux's merits. Ms. Stewart has served her sentence and returned to her business, but thousands of patients continued to be denied access to a drug that has been known all along to work for their disease. An estimated 11,000 people die every year from SCCHN.

The Abigail Alliance expresses its relief that patients suffering from Head and Neck Cancers will finally have access to Erbitux as an on-label use. It has been nearly five years since we lost our Abigail to this disease, after she was unable to obtain Erbitux through any clinical trial or compassionate use program. In their press release, the FDA touted this approval as conducted under an accelerated "priority" review.

The FDA may excuse this delay as the fault of industry, pointing to delays in the sponsor's application for SCCHN, and the now-famous technical issues with the 2001 application for colon cancer. However, it is the government, and not industry, who created the bureaucratic nightmare that constitutes our drug approval process. The FDA simply must address its numerous problems, and Congress must pass measures that make those fixes permanent.

Such measures would include: - streamlined, not just accelerated, approval processes for drugs that help patients faced with life-threatening illness, - ending regulatory disincentives against providing pre-approval access to these drugs, - providing full funding and dedicated leadership for the FDA's critical path modernization initiatives, and - ending the gridlock over unrelated social issues which keeps the FDA from having a confirmed and empowered commissioner.

More Americans die of treatable disease every year than have died from hurricanes, terrorist acts, and war combined since 2001. Congress needs to respond to this tragedy with the ardor they give to those matters. It's time to bring meaningful reform to the FDA.

Frank Burroughs, President, Abigail Alliance www.abigail-alliance.org

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