Your Bio-Identical Hormone Pellets are at Risk. Act Now to Stop Senate Bill 959
Senate Bill 959 is working its way through the Senate Health Education Labor and Pensions committee. This Bill is attempting to establish the authority for the Secretary of Health and Human Services to be able to set a list of drugs and medicines that compounding pharmacies cannot manufacture. The authority is not limited or restricted by regulation, it is not constrained by the requirement to conduct research or acquire data sufficient to make a scientific decision. The bill does not require or establish any operational guidelines for the Secretary to use in making such decisions. The Secretary of HHS can make the decision to ban a particular medication from being produced in the US or by a compounding pharmacy without reason, but just her signature.
What frightens us about this bill is that it gives one agency tremendous power and we believe that will lead to serious negative unintended consequences if it passes. Lets look at one recent example. There was a medicine that was approved by the FDA. This approval procedure followed all the regulatory protocols. The scientists conducted the studies, the committees met, and the recommendation was made. This medicine should be put in all pharmacies without restriction to public access. The Secretary of HHS concluded unilaterally based on her personal belief as a “mother” not as a scientist, a physician, or a research specialist, but as a “mother” , that the decision of the scientists following the protocols violated her personal beliefs, so the medication was not put in pharmacies and made available to the public . As a result she forbade the release of this medicine, contrary to every fact and all medical evidence. Do you think that one appointed politician should have the power over your access to a needed drug?
We do not want a single individual regardless of their bias or orientation to be the choke point of medical approval. We want established safe ways for our compounding pharmacies to operate. We want them regulated for safety and sanitation, but want choice and access to medications, but we do not want them regulated for political, economic or “moral” advantage for any group.