Published: November 13, 2012
WASHINGTON — Despite two decades of dire health warnings and threats of federal intervention, the specialty drugmakers at the center of the nation’s deadly meningitis outbreak have repeatedly staved off tougher federal oversight with the help of powerful allies in Congress.
Over the years, industry friends like Tom DeLay, the former House Republican leader from Texas, have come to its defense. Even Senator Edward M. Kennedy, regarded as the strongest health care advocate in Congress in recent times, dropped efforts to impose new safeguards.
But the pharmacists known as compounders are now facing their biggest regulatory threat as they confront questions on Wednesday and Thursday at Congressional hearings on the deadly outbreak. The question is whether Congress will move to oversee the niche industry more aggressively.
“A lot of the blame for the meningitis situation lies at Congress’s door,” said Larry D. Sasich, a research pharmacist who has written about compounders’ safety record. For specially mixed drugs that fall into a gray area of federal law, he said, “the protections for your cat or dog are stronger than for your wife and children.”
By Washington standards, the industry’s financial clout is not terribly large. The main trade group, the International Academy of Compounding Pharmacists, has spent $1.1 million on lobbying in the past decade, while major players in the business have given at least $300,000 to candidates since 2008, according to data from the Center for Responsive Politics, a research group in Washington.
But by positioning itself as a more affordable, community-based alternative to huge drug manufacturers, compounders have attracted broad support from politicians. They have become popular among proponents of hormone therapy to slow aging and advocates for the autistic, who often distrust the traditional pharmaceutical industry, and rely on compounders’ tailor-made blends.
If history is a guide, it often takes a disaster to get real change in the law.
In 1938, Congress passed the Food, Drug and Cosmetic Act after a drug company mixed an antibiotic with a toxic solvent and more than 100 people were killed, many of them children. In 1962, it amended that act to effectively create the modern drug approval system after thalidomide, a German drug intended to treat morning sickness in pregnant women, caused severe birth defects in Europe, said Kevin Outterson, an associate professor of law at Boston University.
Experts say the magnitude of the current crisis, in which more than 400 people have been sickened with meningitis and 32 have died, may finally spur action. This week’s hearings are expected to include testimony from the head of the Food and Drug Administration and the head of the Massachusetts pharmacy that produced the tainted drug.
Much of the scrutiny has focused on lax oversight by state boards and the Food and Drug Administration. But public health and drug industry experts say Congress is partly to blame for failing to clearly define the F.D.A.’s authority to police the practice.
A familiar cycle has played out in Washington since the 1990s: Publicity over illnesses or deaths from compounding drugs prompts outrage. Expert witnesses warn of the dangers of an unregulated industry. Proposals to fix the system follow. Then nothing happens.
“The public is at risk, an alarming great risk,” one pharmacist warned in 2003 Senate testimony after one person died and five more fell ill from contaminated medicine in 2002 produced by a South Carolina pharmacy.
Compounding, the practice of mixing medicines for individual patients, has grown in recent decades, helping fill gaps during drug shortages and offering cheaper versions of commercial drugs. But it has also become prone to abuse, with some pharmacies becoming, in effect, mini-drug manufacturers.
While the F.D.A. has clear authority to regulate drug manufacturers, state authorities have the main jurisdiction over pharmacies. Determining which category a company falls into is difficult because compounders are not required to give the F.D.A. access to their books.
Ultimately, stronger regulation has been stymied by sharp opposition from the industry and its defenders in Congress, both Democrats and Republicans, many of whom have compounders in their districts.
In 2008, the F.D.A. challenged what it said were misleading claims by compounders that their hormone therapy for older women was safer and more natural than that of big drug makers; it was met with staunch opposition, including objections from Suzanne Somers, the celebrity anti-aging advocate. The agency eventually prevailed.
Hundreds of members of Congress have attended conferences or taken part in charitable events and letter-writing campaigns organized by the International Academy of Compounding Pharmacists. The trade group said recently that its Congressional supporters had surged in recent years and that compounding had “gone from being a little-known practice to having a strong and steady presence in Washington.”
Texas, home to many compounding pharmacies and their main trade lobbying group, has been an important base of support, producing industry allies like Mr. DeLay and Representative Joe L. Barton, a Texas Republican.
In 2003, Mr. DeLay helped ensure that a Senate proposal to re-establish an F.D.A. advisory oversight committee on compounding did not make it into a Medicare bill in the House. His office said at the time that regulating compounders was best left to the states. His opposition to a more active federal role, his office said, was not influenced by about $15,000 in donations from compounders in Texas.
Four years later, Mr. Kennedy floated but then dropped a proposal to toughen compounding rules. In recent interviews, officials blamed intense industry lobbying for the plan’s collapse. According to the trade association, hundreds of representatives from 30 compounding companies visited more than 285 Congressional offices in an all-out lobbying effort that year.
“It was just ‘Oppose this bill — period,’ ” said a Congressional aide involved in the discussions, who spoke on condition of anonymity because he did not want to involve his current employer.
In a small number of cases where the F.D.A. has succeeded in getting stronger rules, the industry has fought back. In 2006, the industry secured signatures from 66 lawmakers on a letter urging the F.D.A. to withdraw a rule on veterinary drugs that prohibits compounders from using bulk ingredients and chemicals.
No such prohibition exists for drugs to treat humans, making the restrictions on animal compounding actually tougher than those for people. Compounders complain that they are unable to mix important drugs for veterinarians and have been fighting for eight years to have the F.D.A. rescind the rule.
Beyond the political battles, a tangled mass of litigation has prevented tougher regulations. A major attempt by Congress in 1997 to define compounding and the F.D.A.’s role in overseeing it was thrown out by the Supreme Court in 2002 on the grounds that its curbs on advertising violated the First Amendment. Representative Edward J. Markey, a Massachusetts Democrat whose district was home to the compounding pharmacy that produced the contaminated steroids linked to the meningitis outbreak, proposed a law this month to give the F.D.A. clearer powers over abusive compounders.
Thrust into the political spotlight, compounding leaders have struck a conciliatory tone. “We have people who are dead because of a breakdown in our system, and that has to be addressed,” said David G. Miller, chief executive at the compounding academy.
Publicly at least, the compounders’ usual allies have been noticeably silent. Mr. Barton is a top recipient of political donations from the industry. Described by Mr. Miller’s group as a “dedicated” industry advocate, he has appeared at its policy and fund-raising events and been outspoken in praising compounding.
When Mr. Barton’s office was asked recently about his current position on regulation of the industry, the calls seeking comment were not returned.