We wrote in the Mass Torts segment of this issue about the deadly meningitis outbreak linked to contaminated pain injections and how it has prompted calls for tighter federal regulation of compounding pharmacies. Poor regulation of the “compounding industry” has periodically been blamed for crippling and sometimes fatal injuries. But all of us must realize that this isn’t the first time Congress has pushed for more authority over that industry. The efforts go back to the 1990s. But because of the vigorous pushback by compounding pharmacists, we now have a patchwork of incomplete, overlapping laws, contradictory court rulings and overall uncertainty about how much power the Food and Drug Administration actually has to regulate compounders. From my perspective, it appears the agency has almost no effectual regulatory control over this industry.
The compounding industry in the U.S. has grown into a $3 billion business with 7,500 pharmacies, according to its trade group. Deborah Autor, FDA’s deputy regulatory commissioner, had this to say about the agency’s authority:
It’s incredibly complicated to explain what our authority is and is not, and the nuances of that. The world has changed a lot since the days of mortar and pestle, and this is the time for pharmacists, for lawmakers, for regulators and for doctors to sit down to grapple with this new model of pharmacy compounding.
Compounding pharmacies are believed to be important for patients who need solutions, creams and other medicines customized for things like smaller dosages or to remove ingredients that cause allergies. Unlike drugs that are manufactured for mass-market distribution, these products are not subject to premarket review by the FDA.
All pharmacies, including compounding pharmacies, have long been regulated by state pharmacy boards, many of which date back to the 19th century. At that time nearly all drugs dispensed in the U.S. were individually compounded by pharmacists. The law that created the FDA in 1938 gave the agency strict authority over drug manufacturers, which quickly eclipsed pharmacists as the main producers of prescription medicines. For decades, the state-federal divide persisted, with states overseeing compounding pharmacies and the FDA policing drug manufacturers.
But in the 1990s, FDA regulators began to more closely scrutinize compounding pharmacies, as their number multiplied and some grew into big businesses. Instead of making individualized products based on a physician’s prescription, companies began mass-producing products and promoting them broadly. That led to massive direct-to-consumer advertising by the manufacturers (which is another story). The compounding pharmacies continued to operate, but largely under the radar.
FDA officials have repeatedly stressed the challenges the agency faces policing compounding operations. In fact, some former agency officials say that the FDA is hesitant to act after years of legal battles with lawyers and lobbyists for the industry. The International Academy of Compounding Pharmacists has spent big bucks lobbying Congress in the past decade and has a track record of defeating measures opposed by the industry. A 2003 provision to set up an FDA advisory committee to oversee compounders was killed by then-House Majority Leader Tom Delay, who said it would create unnecessary federal interference. Interestingly, Delay represented Sugar Land, Texas, which had in its town the headquarters of the compounding academy.
Even when the FDA has succeeded in getting legislation through Congress, the agency has gotten tangled up in the courts. In 1997 Congress passed an FDA-supported law that allowed the agency to regulate compounding pharmacies if they overstepped certain standards for drug production, labeling and advertising. Specifically, the law said that compounding pharmacies were subject to FDA oversight if they advertised their products. A federal appeals court sided with the compounding pharmacies and ruled that this last requirement was unconstitutional and the U.S. Supreme Court agreed with that decision in 2002. But the High Court did not rule on whether the other requirements in the law should stand, creating a legal limbo for regulators. Since then, different appeals courts have issued conflicting judgments on the remainder of the law, which could wind up back at the Supreme Court.
Interestingly, some former FDA lawyers believe new laws are not necessary when dealing with companies that have clearly crossed the line from compounding drugs to full-blown manufacturing. Sheldon Bradshaw, former FDA chief counsel during the Bush administration and now a lawyer in Washington, stated:
Legislation isn’t necessary here. FDA already has all the authority they need to go after the New England Compounding Centers of the world. I’m honestly shocked by how FDA is now downplaying its authority in this regard.
Considering the tragic events arising out of the meningitis health outbreak caused by the New England compounding pharmacy, Congress may now do the right thing and give the FDA the clear authority to regulate this industry. Unfortunately, lots of folks have been hurt and at press time 23 had died in the recent meningitis outbreak. Unfortunately, this is a tragedy that is still unfolding. But the bottom line is this industry must be properly regulated. Congress must act to see that it happens.
Source: Claims Journal
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