U.S. Senate Bill S.959 harms pregnant women by denying them access to affordable medication that protects against premature birth. S.959 would also vastly expand the power of the Food & Drug Administration (FDA) to write new regulations, which would likely include new interference by the FDA with adult stem cell treatments.
Several of the coalition letter supporters will "score" the vote on S.959 on their congressional scorecards.
Originally intended to address a meningitis outbreak that was traced to contaminated steroid injections made by a compounding pharmacy, S.959 epitomizes the concept of "never let a crisis go to waste," states the letter.
Many women are prone to miscarry or to give birth prematurely, resulting in high risk of infant death or serious disability. Some women resort to abortion when told that premature birth is likely. There is a medication to help safeguard the pregnancy: 17 alpha-hydroxyprogesterone ("17P"), which is a synthetic form of the female hormone progesterone. Compounding pharmacies have been providing 17P for more than 10 years. But S.959 contains provisions that greatly expand the definition of "copying," which would effectively prohibit compounding pharmacies from making this and other FDA-approved, but non-patented, medications. One drug manufacturer produces this (non-patented) drug at an astronomical list price of $690 per injection per week, totaling $13,800 per pregnancy. Compounding pharmacies currently provide this same medication for $15-$20 per injection per week, totaling only $300-$400 per pregnancy.
S.959 also vastly expands the power of the FDA over compounded and biological products, exempting blood transfusions but not adult stem cell treatments. Adult stem cells have great promise in treating degenerative conditions, such as osteoarthritis, possibly preventing joint replacements and back surgery. They may also lead to breakthroughs in supposedly hopeless neurologic conditions: spinal cord injuries, traumatic brain injuries, multiple sclerosis, cerebral palsy, and perhaps even Alzheimer's. But these individualized, tailor-made treatments could never meet FDA requirements suitable only for mass-produced, patentable drugs and devices.
S.959 authorizes the FDA to write new regulations that could shut down nearly all remaining adult stem cell treatments. The FDA already prohibits as many types of adult stem cell treatments as it can, forcing at least one major adult stem cell company to move to Mexico and shutting down another by court order. But FDA power currently has limitations. S.959 would empower the FDA to end most remaining adult stem cell treatments by extending FDA authority over nearly all compounded and biological products.
Because of its effect on the unborn and the seriously ill or injured, S.959 is anti-life as well as anti-innovation and anti-competition. It will not only increase medical costs but make some treatments unavailable at any price.
Theis a national organization representing physicians in all specialties, founded in 1943.
SOURCE Association of American Physicians and Surgeons (AAPS)