Senators strike back: FDA tightened restrictions on compounders challenged

June 10, 2015

Blog Post

Since a fungal meningitis outbreak in 2012, the Food and Drug Administration has been tightening restrictions on pharmacies that prepare personalized medications for patients (also known as compounding pharmacies). Most recently, the FDA issued draft guidelines that will place restrictions on the amount of time patients can use certain drugs. For example – Avastin, a cancer medicine used to treat macular degeneration, would be subject to a “beyond use date” limit of only four hours. If a facility conducts a compatibility study on the syringe to ensure product integrity, this could be extended up to five days. But even so, this time period is surprisingly short. Avastin costs about $50 per injection, while Lucentis, a drug approved for use with macular degeneration, costs $2,000.

Sens. Susan Collins (R-Maine) and Claire McCaskill (D-Mo.) noticed this extreme disparity and responded. In a letter to the Department of Health and Human Services, they raised concerns about the new guidelines and the effect on Avastin. The senators note that the guidelines will effectively prohibit the use of Avastin and drastically increase the costs to government healthcare programs. Additionally, the guidelines’ “beyond use dates” are far more restrictive than those practitioners typically use with Avastin.

The senators have demanded a response from the FDA that requires adverse inference reports and relevant regulations. Their letter stands out as notable opposition to the FDA’s ever-continuing efforts to restrict compounding pharmacies.

Over the past 24 months, the U.S. Department of Health and Human Services Office for Civil Rights has brought notable enforcement efforts against several non-profit covered entities and business associates, resulting in instances of six and seven-figure penalties against providers across the county for incidents involving breaches of protected health information.

A new amendment to New York state law, which would have required all healthcare providers to obtain separate consents from patients for treatment and payment is on hold until further guidance is released, according to the New York Department of Health.

On November 1, 2024, the Centers for Medicare & Medicaid Services issued the Medicare Physician Fee Schedule 2025 final rule, which establishes new advanced primary care management billing codes that will expand opportunities for physician practices, federally qualified health centers, rural health clinics and other health care providers to get paid for services provided by clinical staff under the direction of a physician, nurse practitioner or physician assistant beginning January 1, 2025.

Senators strike back: FDA tightened restrictions on compounders challenged

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