Letter to Margaret Hamburg, M.D., Commissioner of Food and Drugs of the US Food and Drug Administration - Applauding FDA's Decision Not to Punish Pharmacies

Letter

U.S. Representatives Joe Courtney (D-Conn.) and Allyson Schwartz (D-Penn.) today sent a letter to the U.S. Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg applauding the FDA's decision not to take enforcement actions against pharmacies that produce a compounded drug that has been in use for decades to prevent pre-term labor in high-risk women. Makena, recently approved by the FDA, is a branded version of the drug recently priced at $1,500 per injection by the manufacturer KV Pharmaceuticals.

For years the compounded version has been available to women at a cost of $10 to $20 per injection, or $200 to $400 for the total treatment. Makena would cost patients a total of $30,000.

Now that Makena has been granted market exclusivity and orphan drug status by the FDA, the sticker shock to both private and public payers--including the Medicaid program--will have dire health and financial consequences without continued availability of the compounded drug.

The FDA's decision will provide relief to both patients and taxpayers. The full text of Courtney and Schwartz's letter is below:

March 30, 2011

Margaret Hamburg, M.D.
Commissioner of Food and Drugs
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993.

Dear Dr. Hamburg:

Since approval of Makena (hydroxyprogesterone caproate) last month, the price of the branded drug has sent shockwaves through provider and patient communities. The Food and Drug Administration's (FDA) announcement today that it will not take enforcement action against compounded hydroxyprogesterone caproate, which has been a safe and affordable treatment option for decades, is a welcome and needed response to Makena's unrealistic costs. More importantly, the announcement reflects a decision that prioritizes patients, providers, and the American taxpayer. While we welcome this clarification, we encourage you to remain steadfast in your decision not to take enforcement action against providers or pharmacists that determine compounded hydroxyprogesterone caproate is appropriate for and meets the needs of their patients.

For nearly 30 years, OB-GYNs have relied on a compounded hydroxyprogesterone caproate formula as a safe and affordable treatment option to reduce the risk of preterm pregnancies. In fact, a 2003 study sponsored by the National Institutes of Health (NIH) confirmed that the compounded hydroxyprogesterone caproate was effective in reducing the incidence of preterm birth and the FDA's own MedWatch has not reported a single consumer or provider safety complaint. More importantly, the treatment has been accessible with prices ranging from $10 to $20 per dose, or one percent of the current cost of Makena. Now that Makena has been granted market exclusivity and orphan drug status by the FDA, the sticker shock to both private and public payers--including the Medicaid program--will have dire health and financial consequences without continued availability of compounded hydroxyprogesterone caproate.

For those without insurance, the price will be unaffordable for many at-risk expecting mothers, which may lead to limited prevention and more premature births. For those with coverage through state Medicaid programs, the thousand-fold price increase adds to the burden of otherwise strained state budgets. And, the high price will likely impact those with insurance coverage as costs are spread among insurance pools, which will ultimately lead to higher premiums. Clearly, the ripple effects of Makena's price tag are far reaching and catastrophic to both women at risk of pre-term labor and the health system that seeks to care for them. These consequences can be avoided with continued availability of compounded hydroxyprogesterone caproate.

In announcing approval of Makena, the deputy director of the FDA's Office of New Drugs points out that "preterm birth is a significant public health issue in the United States." This is undoubtedly true and according to the American Congress of Obstetricians and Gynecologists (ACOG) more than 500,000 babies in the U.S. are born prematurely every year, which costs the U.S. an estimated $26.2 billion annually. Unfortunately, Makena will likely be cost-prohibitive and may exacerbate these already daunting statistics. Therefore, we believe it necessary that the FDA continue to exercise enforcement discretion and refrain from taking any action against prescribers and pharmacists who determine that a compounded hydroxyprogesterone caproate product is in the best interest of their patients. Nothing in the current law prohibits such a clinical decision. Nothing in current law requires the FDA to take action against the compounding of hydroxyprogesterone caproate or any other FDA approved drug product so long as the compounding pharmacy is not marketing, promoting or manufacturing the product.

Thank you for your announcement today and again, we would encourage the FDA to continue to refrain from taking enforcement policies against prescribers and pharmacists who determine compound hydroxyprogesterone caproate on behalf of their patients.

Sincerely,

JOE COURTNEY ALLYSON SCHWARTZ
Member of Congress Member of Congress

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