DearColleague.us

Letter

Gwen Moore

From the office of:

Gwen Moore

 

From: The Honorable Gwen Moore
Sent By: steffany.stern@mail.house.gov
Date: 2/25/2014

Dear Colleague,
We encourage you to join us in sending a letter to the Food and Drug Administration, applauding the agency for its proposed regulation allowing generic drug manufacturers to improve and update their labeling with the most current safety warnings—just as brand-name drug manufacturers are able to do. We support this proposed rule in part because it will make women and health professionals aware of safety hazards sooner and it will have positive effects on legal rights of women. Currently, women who have been harmed by the generic version of a drug have no legal recourse, even if the manufacturer knew or should have known of a safety issue but did not warn consumers.
To join us in signing the letter below, please contact Steffany Stern (Steffany.stern@mail.house.gov or 225-4572) in the office of Congresswoman Gwen Moore.
Sincerely,
Gwen Moore                           Bruce L. Braley                              Louise McIntosh Slaughter
Member of Congress                Member of Congress                      Member of Congress
The Honorable Margaret A. Hamburg
Commissioner
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 51, Room 6304
Silver Spring, MD 20993-0002
Dear Dr. Hamburg,
We are writing to express our pleasure that the Food and Drug Administration (FDA) has proposed a rule that would allow generic drug manufacturers to utilize the changes being effected (CBE) process to update their safety labeling.  (78 Fed. Reg. 67985).  It is essential that all Americans, and in particular women, are informed of all of a drugs’ risks and benefits as quickly as possible.  When it comes to prescription medication, there are many crucial differences between men and women. Women often react differently to medications than men, are more vulnerable to some diseases than men, and may have different symptoms than men when suffering from the same condition.  In addition, women have a myriad of unique health issues such as obstetric or gynecological conditions.  As a result, updating the drug labeling regulations to allow generic drug manufacturers to update drug safety labels as soon as they become aware of a new safety hazard will be extremely beneficial to women.
Most Americans are unaware that the prescription drug that they were prescribed by their doctor may cause harmful complications that are not represented on the drug safety label because of regulatory limitations that do not allow generic drug manufacturers to update their labels to accurately reflect all of the side effects or risks.  Even worse, in 2011, the Supreme Court decided Pliva v. Mensing and as a result consumers who are harmed by the generic version of a prescription drug have been unable to seek relief from the drug’s manufacturer.  The Court held that generic manufacturers could not be held responsible for inadequate labeling because they lack authority to update their warning labels, even if they become aware of new safety problems.  As a result women like Krislyn Smith have no recourse when harmed by a generic drug even when the drug manufacturer knew or should have known of the problem.  
Krislyn Smith was a healthy 27-year-old taking Zarah, the generic form of the popular birth control pill Yaz, when she became dizzy and fainted.  She was rushed to the emergency room where she again fainted.  Tests revealed Krislyn had an enlarged heart, elevated heart rate, and blood clots in both of her lungs, which prevented oxygen from getting to her heart.  Krislyn spent five days in the hospital, including three days in intensive care fighting for her life.  Over the next six months Krislyn required careful monitoring, including heavy doses of blood thinners and blood drawn a few times a week.  At high risk for blood clots for the rest of her life, Krislyn has been to the emergency room twice to check for an elevated heart rate and blood clots.  Her medical bills totaled over $50,000 and were paid by Krislyn, her parents and her medical insurance.  Because Krislyn was on the generic version of Yaz, she has no legal recourse to help pay for her medical bills caused by Zarah.
Generic prescription drugs have an immense market share.  Typically, around 90% of all prescriptions get filled with generic drugs within months of their introduction into the marketplace.  When you combine the pervasiveness of generic drugs with the fact that many potential drug safety hazards are not discovered until years after drugs have been on the market, this poses an unnecessary risk to women in particular.  The clinical testing of brand name drugs that occurs before the drug hits the market usually involves a small group of patients who take the drug over a short period of time. Many serious risks associated with a drug are not discovered until a larger and more diverse population has been exposed to the drug and the drug has been on the market for a number of years.  Women often can be disproportionately impacted by drug safety hazards because of the physiologic differences between men and women.  These differences may not be accurately represented in the limited pool of patients who use the drug during testing or even when it is approved as a brand name prescription drug.  As a result, it is extremely important that consumers are made aware of any potential safety hazards as soon as possible and in addition, that generic drug manufacturers are incentivized to conduct proper pharmacovigilance.
We believe that the FDA’s proposed rule allowing generic drug manufacturers to  initiate safety labeling changes through the CBE process will improve drug safety and the health of women.   Not only will this proposed rule allow consumers and healthcare professionals to have the most up to date drug safety information earlier but it will also remedy the accountability imbalance that currently exists between generic drugs and brand name drugs.  Additionally, the rule provides a clear timeline to ensure that both the reference listed drug (RLD) and the abbreviated new drug application (ANDA) drug return to labeling parity.  This previously was not the case, and we believe this is an additional safety benefit for consumers. The sooner drug manufacturers update their safety labels with the most up to date information; the sooner consumers can be made aware of this information and can make the best decisions for the health of themselves and their families.  Lastly, the proposed rule takes welcome steps to make drug labeling safety information more accessible to the public through the utilization of technology.  Allowing health care providers and consumers to have access to safety information posted on one unified website during the FDA review process will enable faster communication of important safety information with health care providers and consumers. 
Overall, the FDA’s proposed rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products represents excellent
improvements in the area of consumer health and we believe it will have an excellent impact on women’s health in particular.  We strongly urge the FDA to adopt the proposed rule in its current form as quickly as possible.
Sincerely,