Letter Against U.S. Senate Bill 959

July 2, 2013

Association of American Physicians and Surgeons

Coalition Letter Against U.S. Senate Bill 959

THOSE WISHING TO SIGN THE LETTER SHOULD CONTACT ANDY SCHLAFLY, Esq., General Counsel for the Association of American Physicians and Surgeons, by JULY 7, 2013 at aschlafly [at] aol.com (subject: Sign%20letter%20against%20S.%20959) ( ).

As advocates for patients, including the unborn, we oppose U.S. Senate Bill S.959 due to its very harmful impact on the ability of pregnant women to obtain affordable medication that protects against premature birth.  We also oppose S.959 for how it would 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.

Because of this anti-patient, anti-life impact of S.959, several of the undersigned groups will “score” the vote on S.959 as part of their congressional scorecards.  A vote for S.959 will receive a negative score by these groups.  This bill was originally intended to address a meningitis outbreak that was traced to contaminated steroid injections made by a compounding pharmacy, but S.959 has morphed into something very harmful to patients and the unborn.  S.959 epitomizes the concept of “never let a crisis go to waste,” as it exploits a meningitis outbreak to push an anti-life agenda.

Elimination of Affordable Medication that Prevents Premature Births

Specifically, S.959 eliminates access to affordable medication essential to safeguard against premature births.  A significant percentage of pregnancies are prone to premature birth, which often results in deaths of the unborn children or severe birth defects.  Some women have abortions when told that premature birth is likely, especially when they lack access to affordable medication to safeguard the pregnancy.  A medication exists to help prevent these premature births: 17 alpha-hydroxyprogesterone (“17P”), which is a synthetic form of the female hormone progesterone.  Compounding pharmacies currently provide this medication at an affordable cost to thousands of pregnant women who are prone to premature delivery.

Despite the fact that compounding pharmacies have been providing 17P at an affordable cost for over a decade, 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 cost as high as $1500 per injection per week, totaling as much as $30,000 per pregnancy.  Compounding pharmacies currently provide this same medication for $15-$20 per injection per week, totaling only $300-$400 per pregnancy.  http://www.mysanantonio.com/news/local_news/article/Cost-soars-for-pregnancy-drug-1311879.php#ixzz2VrOdZ07c

S.959 would harm unborn children severely by denying access to this (and other) beneficial compounded medication.  Few pregnant women can afford the cost of up to $30,000-per-pregnancy that the drug manufacturer of this medication charges, and many state Medicaid systems will be unable to afford to pay for this treatment.  Compounded substitutes are the only affordable alternative.  But S.959 severely reduces or prohibits the competition by compounding pharmacies.

Key staffers for the Senate Health, Education, Labor and Pensions (HELP) Committee which drafted this bill are fully aware of this harmful effect of S.959 on pregnant women and unborn children, but will not correct this problem despite requests to do so.  If S.959 passes, then pregnant women predisposed to premature birth will no longer have access to affordable medication to prevent it.

Expansion of FDA Authority to Prohibit Adult Stem Cell Treatments

S.959 vastly expands the power of the FDA over compounded and biological products.  Blood transfusions are exempt from S.959, but adult stem cell treatments are not.

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, perhaps even Alzheimer’s. Potentially, they could even be used to grow a patient’s own replacement organ, without the life-long rejection risk of transplants.

These individualized, tailor-made treatments could never meet FDA requirements suitable only for mass-produced, patentable drugs and devices. It is just as inappropriate for the FDA to regulate them as it would be for the FDA to regulate and shut down blood transfusions.

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.  At least one major adult stem cell company has been forced to move to Mexico, and another adult stem cell treatment has been shut down by a federal court order obtained by the FDA.  But some adult stem cell therapies that are purely intrastate have been able to continue, despite FDA opposition to the maximum extent of current law.

S.959 vastly expands FDA power.  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, except for “human blood and blood components for transfusion.” (S.959, end of Section 2(b), p. 4)  Adult stem cells do not fit into this exemption, which means that the FDA will obtain jurisdiction under S.959 to prohibit nearly all remaining adult stem cell treatments, if this bill passes.

Conclusion

S.959 is the most anti-life bill headed for passage since 2010.  If S.959 passes, then most remaining adult stem cell treatments will cease, and pregnant women will lose affordable access to medication that prevents devastating premature births.  S.959 has already passed out of the Senate HELP Committee without its sponsors’ addressing its anti-life consequences, and S.959 is headed for a vote soon on the Senate floor.

We, the undersigned, urge the rejection of S.959.  Thank you for your consideration of this very important matter.

THOSE WISHING TO SIGN THE LETTER SHOULD CONTACT ANDY SCHLAFLY, Esq., General Counsel for the Association of American Physicians and Surgeons, by JULY 7, 2013 at aschlafly [at] aol.com (subject: Sign%20letter%20against%20S.%20959) ( ).