Rep. Watson Compassionate Access Legislation

Press Release

Congresswoman Diane Watson (D-CA) and U.S. Senator Sam Brownback (R-KS) held a press conference on Wednesday, May 21, 2008, to announce the introduction of the Access, Compassion, Care, and Ethics for Seriously Ill Patients Act. The ACCESS Act seeks to increase terminally ill patients' access to promising treatments in the investigational phase of Food and Drug Administration approval. Rep. Watson issued the following statement regarding the Compassionate Access Legislation:

I want to thank Senator Brownback for his leadership on the ACCESS ACT. I am proud to carry companion legislation over on the other side of the Capitol in the House of Representatives.

In the 1990s, we witnessed a grass-roots movement in the AIDS community for greater access to developmental drugs for terminally ill patients infected with the HIV/AIDS virus. These patients viewed compassionate access as an ethical matter, as a matter between the physician and patient. And why wouldn't anyone whose diagnosis amounted to being handed a death sentence?

The ACCESS ACT expands to its logical conclusion a process of expedited use of promising new drugs and medical devices by patients who are seriously or terminally ill before general marketing begins. The bill creates a conditional approval system for drugs, biological products, and medical devices that is responsive to the needs of seriously ill patients whose diseases are life threatening or may cause irreversible disabilities.

The legislation first ensures that terminally-ill patients have access to promising new drugs and devices at the earliest time, as early as the completed Phase I trials for a new product. It also improves upon the existing accelerated approval process for promising new products by allowing the compassionate use of drugs not yet approved by the FDA that have demonstrated in Phase II trials clinical benefits to seriously ill patients.

The activism of the AIDS community in the 1990s expedited the marketing to the general public of promising antiretroviral drugs. Today it is my understanding that many AIDS drugs do not have to go through the controversial and questionable Phase III testing with placebo controls. Sadly, the expedited approval of promising new drugs for cancer patients and patients with other life-threatening diseases does not receive the same attention or expedited approval. In fact, the FDA's approval process varies from one year to the next.

Making the point, Dr. David Minor, President of the California Kidney Foundation, wrote the following in a letter to a major publication: "In the past 15 years Congress has passed several laws designed to speed new treatments of cancer, yet we seem to be back where we were in 1990. FDA requirements seem to vary from one year to the next: three years ago it approved the drug gefitinib for treatment of patients dying from lung cancer on the basis of non-placebo controlled trials showing tumor shrinkage in 10% of patients. Now that a similar drug, erlotinib, appears more effective in placebo-controlled trials, patients with kidney cancer have to suffer from the tightening of regulations; benefiting 10% of dying patients is seen as no longer good enough."

Such an antiquated and slow-moving FDA approval process is not acceptable to the estimated 570,000 Americans who die from cancer yearly. How many of them could have been saved by expanded clinical trials or compassionate access to developmental drugs? How many of the estimated 33 people who die daily from kidney cancer could be saved by compassionate access to developmental drugs? I believe with a new process in place, some of the hundreds of thousands who die yearly could have been saved by compassionate access to developmental drugs.

The Access Act is balanced and fair. It has built-in safeguards that allow for the continued monitoring of the efficacy of developmental drugs as they are used by seriously or terminally ill patients. The legislation does not put the FDA behind the curve, or ahead of the curve. Instead the ACCESS ACT puts the FDA right on the curve where it should be.

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