FDA Slows Drug Approvals
by Frank Burroughs
Issue 138 - August 26, 2009

An article published in the current issue of the Journal of Clinical Oncology, the journal of the American Society of Clinical Oncology (ASCO), confirms the existence of a serious and long-standing problem in the FDA's Office of Oncology Drug Products - a problem the Abigail Alliance has recognized, explained and tried to correct since early 2003.

The FDA's Office of Oncology Drug Products (OODP) under the leadership of Dr. Richard Pazdur, has been slowing approvals and patient access to new safe and effective cancer drugs, counter to the intent of the Accelerated Approval (AA) program created by Congress in the 1990s.

Although AA was clearly working to the benefit of cancer patients, saving and extending lives, in 2003 OODP decided to increase the requirements for Accelerated Approval to a level effectively equal to those required for Regular Approval. The result has been the elimination of "acceleration" for highly promising new cancer drug approvals.

The article titled Accelerated Approval of Cancer Drugs: Improved Access to Therapeutic Breakthroughs or Early Release of Unsafe and Ineffective Drugs?, authored by twenty experts, found that new cancer drugs receiving Accelerated Approval after 7.3 years of clinical testing reach patients through approval no faster than new cancer drugs that receive Regular Approval (7.2 years). The study also found no significant advantages in the long-term safety and efficacy of the delayed cancer drugs when compared to drugs that had received actual acceleration prior to the start of FDA's approval slowdown.

In 2004, the FDA's assessment of the first decade of the Accelerated Approval program found that speeding up drug approvals using AA had been very successful. The program clearly wasn't broken, didn't need fixing and should have been expanded and optimized to further accelerate the delivery of medical progress.

Instead, beginning in 2003, Dr. Pazdur and OODP decided to "fix" it by effectively eliminating AA. The Abigail Alliance recognized the launch of FDA's Decelerated Approval Initiative for cancer drugs at an Oncologic Drugs Advisory Committee (ODAC) meeting on Phase IV clinical trials in 2003, as evidenced by the following excerpt from the Abigail Alliance article at the link "Decelerated FDA Approval" at www.abigail-alliance.org.

The FDA also should have known - and in fact it is hard to believe that they did not know - that its decelerated approval initiative would be devastating for terminally ill cancer patients whose only hope was gaining access to medical progress while still alive.

Despite the stark truth of what the FDA's new policies would do in slowing translation of new therapies to the clinic and the patients that needed them to live, the FDA forged ahead - rolling out its plans to turn accelerated approval and Phase IV clinical trials into a high risk minefield for sponsors. In fact, on that day in March 2003, the FDA effectively eliminated the accelerated approval pathway as a viable mechanism - the exact opposite of what the FDA should have been doing in this time of accelerating scientific progress against cancer.

From the new article in the Journal of Clinical Oncology:

In May 2008, Richard Pazdur, MD, Director of the Office of Oncology Drug Products of the FDA, publicly stated that the AA regulation continues to be highly successful in facilitating early access to large numbers of novel cancer drugs. The findings of this report suggest an alternative, less positive, interpretation of the recent experience with AA. Although the AA process previously facilitated early access to new oncology drugs, it is now difficult to obtain approval with the AA process. Overall, fewer oncology NMEs receive AA versus regular FDA approval in the recent time period.

The Abigail Alliance hopes that publication of this article in JCO signals a shift away from ASCO's long-standing support of the FDA's Decelerated Approval Initiative, and toward a more scientifically- and medically-sound policy of facilitating the delivery of progress against cancer to patients who need it to stay alive, as quickly as reasonably possible.

Getting Accelerated Approval back on track for cancer drugs is only part of the solution. We can do more to accelerate the delivery of safe and effective medical progress to patients who need it. Please support the ACCESS Act (Access, Compassion, Care, and Ethics for Seriously Ill Patients Act; S.3046 H.R.6270 in the last Congress) when it is reintroduced in Congress later this year. The recent FDA regulations do not solve the problem.

Every drug for cancer and other serious life-threatening illnesses that the Abigail Alliance has pushed for earlier access to in our eight year history is now approved by the FDA! There is not one drug that we pushed for earlier access to that did not make it through the clinical trial process. Many lives could have been saved or extended, if there had been earlier access to these drugs!" As of early 2009 the count is 16 drugs! EVEN the FDA's own Science and Technology Board in their late 2007 report recommended there be a provisional approval mechanism for promising developmental drugs.

Frank Burroughs is president of Abigail Alliance for Better Access to Developmental Drugs.

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