Standing Up for Seniors

To see past surveys click here


Standing Up for America’s Seniors Award

RetireSafe continues to recognize those members of Congress who are not afraid to stand up for America’s seniors. Read more about the award.


RetireSafe, a sponsor at the Florida Conference on Aging, presented a seminar on what's happening in Washington from two different perspectives. Read more...

RetireSafe traveled to Louisville, KY to educate seniors about policy solutions concerning aging in place (AIP) and elder abuse.  Read more...

RetireSafe was a sponsor of the National Association of Nutrition and Aging Services Programs conference in San Diego, California.  Our focus was highlighting the importance of nutrition in allowing older Americans to age in place.

 
 

 

President's Message

Biologic and Biosimilar Survey Results

President Thair Phillips

Click here to see our press release concerning our survey

A couple of weeks ago RetireSafe took a survey of our supporters to find out what they knew about biologics, biosimilars and the safety issues surrounding these new medicines. We found that seniors overwhelmingly support strong patient safeguards for so-called “biosimilar” medications. The survey was taken as federal health officials prepare to release standards for the review and approval of biosimilars—medications that are highly similar but not identical versions of cutting-edge biologic medicines. Biologic medicines treat complex medical conditions, including cancers, autoimmune disorders, and multiple sclerosis.

The survey of 1,467 found that an overwhelming majority of respondents—more than 90 percent—did not know what biosimilar medications were or that the Affordable Care Act enabled the Food and Drug Administration (FDA) to approve the use of biosimilars in the United States. The survey also identified support for patient safety protections, including requiring thorough testing of biosimilars prior to their approval and notification of patients and their physicians whenever a biosimilar is substituted for the original innovator biologic product prescribed.

It is clear that 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.

Among the survey’s key findings:

  • 93 percent did not know that biosimilars cannot be generic versions of biologic drugs—unlike generic versions of chemical drugs that are exact copies;

  • 92 percent did not know that the Affordable Care Act allowed for approval of biosimilars as a new class of drugs that could potentially be substituted for a biologic drug and that this could potentially be done without the knowledge of the patient or the doctor;
  • 92 percent did not know that the FDA has of yet not put forward a requirement that biosimilars must be tested for safety and effectiveness through extensive clinical trials for each condition (e.g., arthritis, cancer…) for which they are approved, in the same way the original biologic drugs were tested.

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 different than 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.

Many survey respondents contributed their own thoughts on the significance of requiring strong safety standards to their own health, including:

  • “My life is dependent on the drugs I must take. A change could harm or even kill me.”
  • “The FDA should require independent research when any medication is to be considered. Research by the manufacturer should only be used to initiate independent studies, prior to ANY medication gaining approval.”

  • “No medication should be substituted without the permission of the patient. People should have information so they may make an informed decision regarding their health and medications.”

  • “I have had problems with a header generic drug that did not have the expensive catalyst that helped the body absorb it correctly. It did not work at all! What can we expect of a biosimilar?”

Given this loud and clear voice RetireSafe is going to be calling on the FDA and elected officials to put in place a series of common-sense safeguards around new medicines in the form of a “Safe Medicines Bill of Rights.”  Patient safety must come first if we are to reap the benefits of these new lifesaving medicines.  You will hear more from us concerning this important issue.

For the full results of the RetireSafe survey, please click here

For more information on biologics and biosimilars click here

More thoughts from President Phillips...

 

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