June 30th, 2016
Dear Friend, New “miracle” drugs called biologics have extended and enhanced the lives of people who have diseases like diabetes, cancer, HIV/AIDS, multiple sclerosis (MS), autoimmune diseases like rheumatoid arthritis, as well as heart attacks and strokes. Maybe you or someone you know has one of these diseases and have been helped by these new life altering drugs.
Obamacare has created a legislative path for drugs that are similar but not the same as the biologics prescribed by your doctor to be substituted and, the FDA (Food and Drug Administration) could continue to allow these drugs to be approved without adequate safety testing.
Right now, proponents of this controversial program argue that it will save the government and taxpayer’s money. But others argue that continuing to put these “similar” drugs on the market without proper testing is dangerous.
These similar drugs (called biosimilars) are intended to be cheaper knock offs of the relatively new “biologic” drugs that can treat, cure or help manage devastating diseases.
It is important to note that biosimilars are not exact copies, but simply similar to the original biologic drugs. Unlike small-cell chemical compounds or pills, biosimilars cannot be “generic” versions of complex large-molecule biologics that are made from living organisms.
Even small differences between the original Biologics and the Obamacare biosimilars could cause the patient’s immune system to think the medicine is a foreign body causing an adverse and possibly life threatening reaction.
Because of the obvious risks associated with substituting copycat biosimilar drugs for the powerful drugs used to treat our most serious and life-threatening diseases, patient groups like RetireSafe have called for commonsense safeguards before, during, and after any biosimilar substitutions. Commonsense safeguards like:
- Biosimilars should not be allowed to be substituted for the drug your doctor ordered for you if it has not been tested for safety and efficacy specifically for the disease or condition (e.g. arthritis, cancer…) it is prescribed to treat.
- Patients who are stabilized on their biologic medication should not be forced to switch to a biosimilar for non-medical reasons.
- Biosimilar drugs should have unique names different from the original drugs to eliminate any confusion for patients, physicians, pharmacists, and regulators.
- Both the patient and the patient’s physician must be informed before or shortly after a biosimilar is substituted for the biologic drug ordered by the doctor.
We have lobbied Washington bureaucrats and Obama administration officials, and testified at the FDA to consider the safety of seniors in this decision. But the FDA went ahead and has already approved 2 of these biosimilars and is preparing to approve several more this year. They have done this without considering these important safety factors.
RetireSafe has been selected to testify in two weeks at the FDA as they consider approving two more biosimilars. We need your input to tell the FDA how you feel.
Thair Phillips – President