WASHINGTON, Sept. 10, 2014 /PRNewswire-USNewswire/ -- The following is a statement on behalf of RetireSafe:
Dear Member of Congress;
We write to you today to bring to your attention a critical safety issue that could affect all Americans, but especially those older Americans who rely on relatively new medicines called "biologics". RetireSafe, a 400,000-supporter strong nationwide advocacy organization for seniors, works hard to give a voice to retired Americans and those who hope to retire. This safety issue concerns us and the over 1,400 senior citizen supporters who specifically answered our survey concerning these critical safety issues.
Americans are blessed to have access to new biologic medicines that can treat devastating diseases like diabetes, cancer, multiple sclerosis (MS), and arthritis. For older Americans, these are truly "miracle" drugs that extend and enhance their lives. They can also be expensive, developed after years of costly research. One effort to provide greater access to these powerful biologics and achieve some savings is the development of "biosimilar" drugs. It is these biosimilar drugs that cause us concern.
There have been two applications for approval of biosimilars that have already been sent to the Food and Drug Administration (FDA), although they have yet to release the full regulations and standards for the review, approval, and use of these biosimilars. These final regulations and standards will be critical to the safety of America's seniors.
A new survey conducted by RetireSafe finds that seniors are largely unaware of biosimilars and that they overwhelmingly support strong patient safeguards and informed consent of and by patients and their physicians. The survey of 1,467 RetireSafe supporters found that more than 90 percent of respondents did not know that biosimilars cannot be generic versions of biologic drugs—unlike generic versions of small-cell chemical drugs that are exact copies. And an equal number didn't know that the Affordable Care Act or "Obamacare" enabled the FDA to approve the use of biosimilars in the United States or that the FDA has yet to put forward strong safety standards.
The survey also found overwhelming support for a strong set of patient safeguards:
- 92 percent wanted a requirement that drug companies test the safety of biosimilars for all conditions the drug will be used to treat;
- 86 percent wanted a requirement that drug companies that are developing biosimilars conduct human clinical trials to ensure a given biosimilar is safe;
- 90 percent believed that the name of the biosimilar should be uniquely different than the name of the original biologic medicine to allow for adequate tracking of any adverse reactions;
- 91 percent want physicians to be notified when a biosimilar is substituted for the original biologic drug they prescribed for their patient;
- 94 percent believe patients should be notified when a biosimilar is substituted for the original drug prescribed by their doctor.
When it comes to new biosimilar drugs, people are rightly concerned and want to keep their drugs safe and effective, so that seniors and other Americans aren't used as guinea pigs for inadequately tested drugs. Seniors have made their voice clear that patient safety must come first if we are to reap the benefits of new lifesaving medicines.
We wanted to alert you to this critical safety issue and ask that you:
- Initiate or support other Members who initiate hearings concerning the safety of biosimilars.
- Encourage the FDA to release their proposed regulations and safety standards concerning biosimilars.
- Propose that the FDA have an open and transparent discussion and comment period so that those affected by these regulations and standards can be involved.
- Tell the FDA that while you support the use of biosimilars, patient safety must be first and foremost!
Please don't hesitate to get back to me with any questions you may have about the survey, and the use of biosimilars as substitutions for biologics.
CONTACT: Thair Phillips, 703-593-2447, [email protected]