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Compounding pharmacies have long evaded the tight oversight governing established drug makers

Seeking new rules, US Representative Edward Markey calls the meningitis outbreak “the tip of an industry iceberg.”
Seeking new rules, US Representative Edward Markey calls the meningitis outbreak “the tip of an industry iceberg.”Chuck Cook for the Boston Globe/File 2010

Lawmakers’ calls for tougher regulation of compounding pharmacies are nothing new. Over decades, there have been a series of attempts at the federal level to rein in a business that has largely evaded the kind of stringent oversight established drug makers face.

Federal regulators have long been flummoxed by the growth of the compounding pharmacy industry, which is made up of thousands of small outfits that specially mix medicines for patients, along with an expanding class of industrial-scale manufacturers that ship products to health care providers nationally.

The spotty oversight — veering from lax to tighter scrutiny and slowed by lobbying, aborted legislation, and court decisions — has come into sharper focus since steroid injections traced to the New England Compounding Center in Framingham exposed up to 14,000 patients across the country to fungal meningitis.

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So far, the outbreak has killed 25 people and sickened 354 in 19 states, according to the Centers for Disease Control and Prevention.

Former regulators and legal scholars say the Food and Drug Administration has lacked enough authority and resources to effectively monitor compounding pharmacies.

For example, the type of FDA scrutiny used to approve and inspect new drugs — a tightly choreographed process involving multiple clinical trials and inspections of plants where medicines are made according to strict sterility standards — could not easily be replicated for compounding pharmacies. Such pharmacies custom-produce drugs not always available commercially, including treatments that are in short supply or have been pulled from the market because of a lack of demand.

“To perfectly enforce the statutes, the FDA would need a much larger budget,” said I. Glenn Cohen, an assistant professor at Harvard Law School who codirects its Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. “But they’re doing the best they can, given their resources and the political constraints.”

Congressman Edward J. Markey on Monday released a report outlining the roles of state and federal regulators and how the industry “has historically resisted a federal role” in its oversight. A review by his office of pharmacy board records, FDA compliance records, and news reports since 2001 found 23 deaths and 86 serious illnesses linked to products from compounding pharmacies, excluding the latest meningitis cases.

“The risks of allowing the safety of compounding pharmacies to go largely unregulated have been recognized for years, and the devastating tragedies of this outbreak will be felt well beyond that,” Markey said. “The tragedy of NECC is clearly just the tip of an industry iceberg that has long needed reform and federal oversight.”

For much of its history, the FDA has largely ignored compounding pharmacies, leaving their regulation mostly in the hands of state pharmacy boards, which have created a patchwork of rules and standards. But the low-profile business has long worried many in Washington.

The late Senator Edward M. Kennedy sought to bring clarity when he proposed the Safe Drug Compound Act of 2007. But the legislation never came to a vote because of opposition from compounding pharmacy lobbyists and other trade groups that argued such a law would prevent the speedy delivery of medications not available at traditional pharmacies.

“They made sure the legislation wouldn’t see the light of day,” said Sarah Sellers, a pharmacist and drug safety specialist who worked for the FDA on pharmacy compounding issues in 2006. She is now president of Q-Vigilance, a drug-safety consulting firm in Illinois.

The industry’s main trade group, the International Association of Compounding Pharmacies, opposed Kennedy’s bill because it was “too broad and had the potential to disrupt the important and sometimes life-sustaining relationship between compounders and patients,” said David Ball, a spokesman for the organization. He said the group “continues to believe that state boards of pharmacy have the bulk of the responsibility when it comes to state licensure issues.”

Senator Richard Blumenthal, Democrat of Connecticut, wrote to the FDA this month, demanding stricter oversight of compounding pharmacies such as New England Compounding Center. Markey, a Malden Democrat, has asked the Justice Department to launch a criminal investigation of the Framingham company.

Their calls echoed those from lawmakers and regulators who have tried to govern the industry over the past 20 years as awareness of its risks increased. In 1992, then-FDA Commissioner David Kessler warned the proliferation of unapproved drugs from a “shadow industry” could pose a public safety threat and potentially lead to deaths. Kessler did not respond to requests for an interview.

Compounding pharmacies have also been a concern to pharmaceutical giants that consider them competition, sometimes undercutting their brand-name products by offering cut-rate prices on the same remedies.

FDA officials issued guidelines in 1992, putting compounding pharmacies on notice that regulators could “initiate enforcement actions . . . when the scope and nature of a pharmacy’s activity raises the kinds of concerns normally associated with a manufacturer and that results in significant violations of the [FDA’s] new drug, adulteration, or misbranding provisions.” The guidelines said the agency would defer to state boards on regulation of smaller “traditional” compounding.

The policy set the stage for the FDA Modernization Act, passed by Congress in 1997, which gave the agency more power to treat compounding pharmacies like other drug makers. The law was passed over the objections of the industry’s main lobbying group.

Over the past decade, the association has spent $1.1 million on federal lobbying — a minuscule amount compared with the $153.1 million spent last year alone by the pharmaceutical manufacturing industry.

The compounding pharmacies organization has given $201,324 to candidates from both parties during the current election cycle, according to federal data compiled by the Sunlight Foundation. Representative Charlie Bass, a New Hampshire Republican, got $10,000 from the trade group. It also donated $6,000 each to Senator Orrin Hatch, a Republican from Utah, and Senator Sherrod Brown, a Democrat from Ohio.

This month, Senator Scott Brown said he would donate $10,000 to the Meningitis Foundation of America, the same amount the Massachusetts Republican got from the owners and executives of the New England Compounding Center.

After a group of compounding pharmacies filed a lawsuit challenging the 1997 law, the US Supreme Court in 2002 struck down a portion of the law limiting advertising by compounding pharmacies, ruling it violated the right to free speech. That decision was later interpreted in some lower courts as stripping away the FDA’s ability to regulate the compounding industry.

While the FDA continued to oversee compounding pharmacies under its compliance policy guidelines — by, among other things, sending warning letters that in some cases led to pharmacies being shut down — the lobbying group redoubled efforts to fend off more stringent regulation. Most notably, it foiled attempts in Congress, including the one by Kennedy and other lawmakers in 2007, to give the FDA broader authority to inspect facilities and control the sale of compounded drugs.

“Clearly, the industry and trade groups would like less oversight and less regulation and have lobbied for that over the past 10 years,” said Dr. Michael Carome, deputy director of health research for Public Citizen, a consumer advocacy group that has long been concerned about the industry.

Carome faulted the FDA for not doing more, using the agency’s existing authority.

“We’re not saying there is no need for further regulation,” he said, “but our fundamental position is that current laws give the FDA more than enough authority to have prevented this outbreak of fungal meningitis.”

Before the meningitis crisis, the compounding industry had been attempting to raise its profile by running commercials on airport televisions. After the news about the infections, the International Academy of Compounding Pharmacists hired a Newton public relations firm to field questions about compounding companies.

“For too long, compounding pharmacies have been governed by fragmented regulations and inconsistent oversight,” said Markey, the senior Democrat on the House Energy and Commerce Committee, which has jurisdiction over the FDA. “This tragedy now demands the strongest response from Congress and federal and state authorities.”

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