[Congressional Record (Bound Edition), Volume 152 (2006), Part 12]
[Extensions of Remarks]
[Pages 16278-16279]
[From the U.S. Government Publishing Office, www.gpo.gov]




        THE ``SWIFT APPROVAL, FULL EVALUATION (SAFE) DRUG ACT''

                                 ______
                                 

                         HON. EDWARD J. MARKEY

                            of massachusetts

                    in the house of representatives

                        Thursday, July 27, 2006

  Mr. MARKEY. Mr. Speaker, I rise today to introduce the Swift 
Approval, Full Evaluation (SAFE) Drug Act. This bill is designed to 
ensure that the FDA can balance the need to get important life-saving 
drugs to the market quickly while ensuring the drugs get the full 
evaluation they need to ensure the safety of those products. A strong 
postmarketing study system allows the FDA to achieve a careful balance 
between speed of approval and careful scrutiny of the products. 
However, as both the GAO and the Inspector General of HHS recently 
reported, the system to ensure that postmarketing studies are conducted 
and completed is broken and the FDA has not made reform a priority.
  Postmarketing studies are important because they prevent death, 
detrimental reliance and waste. They provide critical information about 
the risks and benefits of a drug after it has been approved and on the 
market. They can also provide additional information about optimal use 
of the product and what groups of people are most likely to benefit (or 
not benefit) from use. Since the long-term effects of products are not 
usually studied prior to approval, postmarketing studies provide 
critical information about the risks or benefits of long-term use. 
Postmarketing studies allow the FDA to approve drugs for to consumers 
who need them quickly while ensuring that scientists will continue to 
investigate the best uses of the drug. These studies are particularly 
important when, in the interest of speeding drugs to consumers, the 
drugs are approved under the FDA's accelerated approval process.
  In 1992, the Food and Drug Administration, FDA, established a process 
that amounted to a trade-off between its mission to ensure drug safety 
and effectiveness and the need to speed promising new drugs to market 
to increase treatment options for life-threatening illnesses. Called 
accelerated approval, this process allows FDA to approve a drug on an 
expedited basis using promising but limited information about its 
safety and effectiveness, but only on the condition that the company 
agrees to conduct further studies to confirm the safety and 
effectiveness of the product. Under the law, drug companies are 
required to do additional studies to confirm that the drug is safe, 
effective and works for its approved indication.
  The importance of conducting postmarketing studies to ensure the 
safety of drugs approved through accelerated approval is illustrated by 
the example of encainide and flecainide. In the 1980's encainide and 
flecainide were approved to treat ventricular arrhythmia after 
myocardial infarcation. Arrhythmias are a risk factor for heart attacks 
and encainide and flecainide are very good at suppressing arrhythmias. 
People assumed that because the drugs were good at suppressing 
arrhythmias, they would also prevent heart attacks. While this 
treatment was on the market between 250,000 and 500,000 people were 
prescribed the drug every year to prevent heart attacks. When the 
postmarketing clinical trial was conducted to confirm that encainide 
and flecainide did in fact reduce heart attacks, the study found these 
drugs actually tripled the rate of death. The drugs were withdrawn from 
the market. If the postmarketing study had never been completed, 
doctors would have continued to prescribe a drug that they thought was 
beneficial but was actually killing people.
  Postmarketing studies are also important to ensure that drugs 
approved through accelerated approval actually work. In May 2003, 
Iressa, which is manufactured by AstraZeneca, was approved under the 
accelerated approval process for treatment of non-small cell lung 
cancer in individuals who have failed to respond to two or more courses 
of chemotherapy. Iressa showed promise in early studies. The FDA 
approved Iressa, on the condition that AstraZeneca continue research on 
the drug to confirm the early results. Complying with the FDA's 
mandate, AstraZeneca conducted a postmarketing study and found that, 
for most people, Iressa was not effective. The drug was withdrawn from 
the market. This trial provided critical information to both physicians 
and patients who are trying to determine the best course of treatment 
for this horrible disease. If the postmarketing study had never been 
completed, doctors would have continued to prescribe it and patients 
would have continued to spend $1,800 a month for a drug that is 
ineffective for most patients when there are alternative treatments 
available.
  Unfortunately, many companies fail to conduct the postmarketing 
studies they promised to complete as a condition of approval on a 
timely basis and the public may go years without knowing whether the 
drugs approved through accelerated approval are really safe and 
effective. According to information provided by the FDA to my staff on 
March 30, 2005, drug companies take a very long time before they even 
initiate postmarketing studies that are required as a condition of 
approval as of March 9, 2005; companies with outstanding trials had 
been selling these products to the public for an average of 1 year and 
10 months and up to 6 years and 9 months without even initiating the 
required studies.
  Despite the fact that companies often wait years before starting 
required postmarketing studies, the FDA has never used the only 
mechanism it has to enforce compliance with the requirement: withdrawal 
of the product. According to the HHS IG, ``Currently, short of 
withdrawing a drug from the market--a remedy available to FDA only in 
limited circumstances--the only short-term, practical options available 
to FDA in dealing with drug applicants that do not comply with the 
terms of their commitments are sending letters and placing phone calls. 
Providing FDA reviewers with additional tools, such as the ability to 
impose monetary fines, may send a signal to drug applicants that there 
are consequences when postmarketing study commitments are not 
fulfilled.'' The SAFE Drug Act will provide additional enforcement 
mechanisms.
  The system of tracking postmarket safety issues and monitoring and 
enforcing postmarketing studies is broken and failing to ensure patient 
safety. The SAFE Drug Act will address these problems by:
  (1) Providing the FDA with authority to require postmarketing studies 
and enforce the prompt completion of those studies;
  (2) Providing the FDA with mechanisms to help monitor the progress of 
postmarketing studies;
  (3) Providing the Secretary with the authority to require that the 
label include specific wording to ensure safe and effective use of a 
product including special labeling to help consumers identify 
accelerated approved drugs or biologics until converted to full 
approval;
  (4) Restricting direct to consumer advertising for accelerated 
approved drugs or biologics until converted to full approval;
  (5) Providing FDA employees with enhanced whistleblower protections 
if they are retaliated against for reporting violations of laws or 
regulations or a significant threat to public health and safety to 
Congress, GAO, Federal Agencies, or their bosses; and
  (6) Requires reports to Congress on the systems to track 
postmarketing safety issues and approvals that are based on Non-
Inferiority Trials.
  According to a recent Wall Street Journal Online/Harris Interactive 
health-care poll, a majority of the American public is concerned about 
the FDA's ability to ensure the safety and efficacy of drugs. We need 
to stop the

[[Page 16279]]

erosion of public confidence in the FDA, reform the system of 
postmarketing studies, and ensure that FDA balances the desire to speed 
drugs to market with its critical role as the watchdog of public 
health. I urge my colleagues to support the SAFE Drug Act.

                          ____________________