Published October 11, 2012
Powerful Democrats in Congress are calling for a Congressional inquiry as well as tighter federal oversight in the wake of the deadly nationwide meningitis outbreak.
It’s a fight that could land in the U.S. Supreme Court.
Sen. Richard Blumenthal (D-Conn.), Representatives Henry Waxman (D-Calif.) and Edward Markey, (D-Mass.), among others, are calling for tighter federal oversight. Legislation could be introduced to strengthen the regulatory authority of the federal Food and Drug Administration.
It’s been estimated as many as 13,000 people in 23 U.S. states may have been exposed to the steroid infected with a meningitis-inducing fungus that was sold by the specialty pharmacy New England Compounding Center in Framingham, Mass.
An estimated 121 have been sickened nationwide, with 12 people dying.
As it stands now, the FDA oversees drug ingredients, not pharmacies, including those operating as compounders. Instead, the compounders are subject to a patchwork of state oversight, notes Rep. Waxman.
That has led to calls for more regulation by the FDA. Pharmacies in the past have successfully fought federal oversight in the courts, eventually ending up before the U.S. Supreme Court. However, more federal regulation could actually take drugs off the market.
Says who? The government itself, which acknowledged that in a 2002 U.S. Supreme Court case that struck down portions of the Food and Drug Modernization Act of 1997.
At risk now is a new regulatory scheme that could hurt patients needing the compounded drugs by forcing the medicines they need off the market.
More than 55,000 pharmacies dot the country, with about half conducting compounding, mixing batches of drugs for sale or repackaging drugs for off-label use, according to the International Academy of Compounding Pharmacists.
The 1997 Food and Drug Administration Modernization Act indicates that federal restrictions don't apply to medications compounded for individual patients based on “the unsolicited receipt of a valid prescription order."
However, Massachusetts Gov. Deval Patrick is now stating that the Massachusetts specialty pharmacy operated outside its state license by selling compounded drugs across state lines.
If the FDA is granted broader powers, this fight could end up in court again. The courts would have to contend with the issue of federal expansion of the power to regulate business activity in the states. Congress’s powers here are restricted by the U.S. Commerce clause, notes Judge Andrew Napolitano, FOX News legal expert.
And here’s what’s breaking now in D.C. about this: Energy and Commerce Committee Ranking Member Waxman, Health Subcommittee Ranking Member Frank Pallone, Jr., and Oversight and Investigations Subcommittee Ranking Member Diana DeGette have sent a letter to Energy and Commerce Committee Chairman Fred Upton, Health Subcommittee Chairman Joseph Pitts, and Oversight and Investigations Subcommittee Chairman Cliff Stearns “requesting an investigation and hearings on the meningitis outbreak caused by a contaminated injectable steroid manufactured by New England Compounding Center (NECC), a pharmacy compounding facility.”
The members are also demanding “that the Committee act promptly to send letters of inquiry to FDA, NECC, state pharmacy boards, and pain clinics that administered the contaminated drug to better understand how this outbreak occurred and how to prevent future outbreaks."
And Sen. Blumenthal is also demanding action in a letter sent to the FDA. “The recent outbreak of dangerous, potentially deadly disease indicates a clear and present need for stronger accountability and oversight. Stricter scrutiny by the FDA could help prevent contamination of medicines – apparently the cause of this 23-state crisis – produced by such compounding pharmacies.”
Sen. Blumenthal adds: “Their relative immunity from standards of safety and effectiveness seems anomalous and unacceptable. The FDA's authority should be extended if necessary to make and enforce stronger standards that protect the public and assure quality.”
Blumenthal continued, “This tragic incident calls for stronger oversight, more exacting standards and stricter enforcement of consumer and patient protections related to compounding pharmacies. I remain particularly concerned that compounding, which is intended for individual patient special needs, may have grown more broadly in some instances, into widespread and multi-state distribution.”
Blumenthal notes: “Compounding is a process of combining, mixing, or altering ingredients in order to create a medication for a particular patient. Compounding pharmacies can make drugs for patients that are not typically available commercially, such as a drug made in a lower dosage for a child or a drug made without a dye or preservative for a patient with a specific allergy. Pharmacists that compound drugs have been subject to less federal regulation because they make drugs in response to a valid patient prescription, making the safety and efficacy trials required for drug manufacturing impractical and unnecessary.
"Compounding drugs without a patient prescription crosses the line from traditional compounding in limited quantities for specific patient needs to mass production of drugs without proper FDA oversight.”