Conspiracy Of Silence: FDA Allows Drug Companies To Abuse The "Accelerated Approval" Process, Companies Fail To Conduct Follow-Up Studies

CONSPIRACY OF SILENCE: FDA ALLOWS DRUG
COMPANIES TO ABUSE THE "ACCELERATED
APPROVAL" PROCESS, COMPANIES FAIL TO CONDUCT
FOLLOW-UP STUDIES

New Markey report exposes that FDA/drug companies keep patients and investors in
the dark

Washington, DC: Representative Edward J. Markey (D-MA), a Senior Member of the Energy and
Commerce Committee, today will release a staff report: Conspiracy of Silence: How the FDA Allows
Drug Companies to Abuse the Accelerated Approval Process. The report reveals that the majority of
pharmaceutical companies benefiting from the Food and Drug Administration (FDA)'s "accelerated
approval" process, a mechanism designed to expedite drugs for patients with life-threatening illnesses,
have not conducted the post-marketing studies that are required by law on a timely basis. The report
also details information provided by the Security and Exchange Commission (SEC) indicating that
many drug companies have not disclosed information regarding postmarketing studies to their
investors. Of the 91 postmarketing studies required by the FDA, 42 studies have not been completed
and half of the unfinished studies have not even started.
"It is outrageous that drug companies and the FDA have been dragging their feet when it comes to
conducting required postmarketing studies. Pharmaceutical products approved under the accelerated
approval process are designed to treat patients with life threatening illnesses, so ensuring the
effectiveness of these drugs is a life or death matter for many patients," said Representative Markey.
The importance of post-marketing studies is highlighted by the recent case of the drug Iressa which
was approved by the FDA in 2003 under the "accelerated approval" process for treatment of non-small
cell lung cancer. In early studies Iressa caused significant shrinkage in tumors in about 10% of
patients and was expedited to the market. AstraZeneca, the company producing Iressa, complied with
the FDA and conducted a follow up study of approximately 1700 patients. The study revealed that the
cancer therapy showed no survival benefit in comparison to a placebo. The FDA shared the outcome
of the study with the public and suggested alternative treatments. The FDA's announcement of the
AstraZeneca's important trial prevented patients from spending $1,800 a month for a drug that is
ineffective when there are alternative treatments available. The Markey report raises concerns that
other companies who have failed to carry out similar commitments could have similar problems.
"It is very important that those drugs that hold the promise of helping to save lives and reduce pain and
illness get to patients quickly. But this expedited approval process is done under the condition that a
full review of their safety and effectiveness will be a priority for the drug company and the FDA.
After all, a drug tested on a few thousand people for a few months cannot be assumed to be safe for
millions of people to use over the years to come. The data in Markey's report is further evidence of
the need for this Congress to make major reforms in the FDA's post market approval safety system,"
Senior Policy Analyst Bill Vaughan, Consumers Union.
The Markey Report also reveals that pharmaceutical company shareholders may not know about a
company's postmarketing study commitments. According to information provided by the SEC, 68%
of public companies have not disclosed any of their post-marketing study commitments to their
shareholders in their filings with the SEC.
"Not only have the American people been left in the dark about their gamble when taking these drugs,
but investors may have been left in the dark about what the drug companies have been doing - or
failing to do," Rep. Markey said.
"This report exposes failures on two fronts. Some pharmaceutical companies may have failed to
protect their consumers and their shareholders. In turn, the FDA, which is supposed to be the
watchdog of the drug industry, hasn't required companies to adhere to FDA policies on post-marketing
testing. I will be proposing legislation to address the failures of the drug companies and the FDA to do
their due diligence in order to protect patients and doctors across the country. My bill will require that
companies inform patients and physicians when a product has received conditional approval under this
"accelerated approval" system. The legislation will also clarify the law to ensure the FDA has full
authority to require further postmarketing studies after a product is already on the market. I want to
make sure that we put the needs of patients and doctors first, expediting information to the public about
these critical treatments," Rep. Markey.
Rep. Markey, author of legislation to create a federal registry of all clinical trials - to ensure that
pharmaceutical companies disclose the results of all clinical trials, will introduce new legislation next
week aimed at providing information to patients and doctors about "accelerated approval" process
drugs and improving the capacity of the FDA to oversee the postmarketing studies.
The Markey legislation will:
® Require that companies inform patients and physicians when a product has received conditional
approval under the accelerated approval system.
® Require that companies distinguish between a conventional approval and an accelerated
approval with conditions on the product's label.
® Shift the risk-reward analysis in favor of doing the promised studies with
o Civil monetary penalties for failure to conduct studies with due diligence.
o Enhanced penalties associated with any harm that occurs to a consumer because a postmarketing
study was never undertaken or not completed in a timely manner.
® Clarify in statute that the FDA has the authority to require further postmarketing studies after a
product is already on the market.
® Clarify in statute that the FDA has the power to make a change on a product's label.
® Ensure that whistleblowers at the FDA have adequate protections.
For more information on Rep. Markey's legislation and the letters provided to Rep. Markey by the
FDA and Securities and Exchange Commission (SEC) which have provided the evidence for this
report check out: http://www.house.gov/markey/

http://www.house.gov/markey/Issues/iss_health_pr050601.pdf