This rapidly escalating struggle reaches far beyond congressional efforts to rein in reckless compounding pharmacies that began in October after tainted steroids from the Massachusetts-based New England Compounding Center (NECC) were linked to a meningitis outbreak that has killed 48 people.
Amid a public outcry, lawmakers began considering draft legislation to address public safety concerns. With a bill in the works, a range of companies, business associations and health organizations have begun pressing their own interests along a wide front.
Veterinary groups, for instance, have launched their own lobbying campaign opposing the drugmakers. These groups warn that any legislation that required patient-specific prescriptions would deprive them of vital drug stockpiles and that pets would die at their clinics.
Hospitals want to ensure that any new oversight of compounders by the Food and Drug Administration does not cripple the firms’ operations, which could worsen drug shortages.
And the compounders, while agreeing that tighter federal enforcement of safety standards is needed for the large firms, are vigorously resisting the drug companies’ bid to limit competition.
The Senate Health, Education, Labor and Pensions Committee is working on draft legislation directed at compounders and is expected to begin circulating it to interested groups as soon as next month. The House Energy and Commerce Committee, meanwhile, is investigating whether lax oversight of NECC by the FDA contributed to illnesses and deaths.
Since Congress and other federal officials began investigating NECC this fall, the number of groups lobbying on issues related to compounding pharmacies has more than doubled, records show.
“Some are making blatant copies of FDA-approved products,” said Ron Phillips, who is lobbying for the Animal Health Institute, which represents drugmakers. “You can go to any trade show or to their Web sites and they are openly promoting this. A clear line needs to be drawn.”
Over the past two decades, many compounders — who custom-mix medications — have moved from a traditional practice of filling prescriptions for individual patients to mass producing drugs, often without a prescription. Sometimes the drugs are similar to those made by drug manufacturers. Today, compounding is about a $2 billion-a-year industry.
The specialty pharmacists supply about 40 percent of all intravenous medications used in hospitals, up from 16 percent a decade ago, according to industry estimates. Veterinary groups estimate that 20 percent of the medications they prescribe are compounded products.
Compounders also make some of the highest-risk drugs available, sometimes using potent raw ingredients that must go through a critical sterilization process to ensure safety. Many of them are injected directly into patients, such as the steroids linked to the meningitis outbreak, which has sickened 666 people in addition to those who have died.
Yet compounding pharmacies are not required to follow federal safety laws — such as testing their medications for contamination and potency levels — that apply to commercial drugmakers.
As compounders have moved into bulk production, federal regulators have sent conflicting signals about when they will step in.
The drugmaker K-V Pharmaceutical, for instance, won FDA approval in February 2011 for its drug Makena, which is given to pregnant women to prevent premature births, and was given the exclusive right to sell it for seven years. But the following month, the FDA announced it would not take action against pharmacies compounding a similar product.
The day after that announcement, K-V’s stock dropped by more than 60 percent. Since then, the company has cut the per-dose price of Makena from $1,500 to $690.
That episode was widely noted across the drug industry, with compounding experts calling it a watershed moment.
Earlier this winter, officials from K-V Pharmaceuticals were on Capitol Hill for two days, lobbying on the issue and telling congressional staffers that compounded versions of Makena can be “unsafe or ineffective,” said Sarah Sellers, senior director of epidemiology and risk management for K-V’s marketing and distributing arm, Ther-RX.
“If an FDA-approved product is medically appropriate, it should be used preferentially,” Sellers said.
Manufacturers of animal drugs — such as Frontline for flea and tick prevention and Heartgard for heartworm prevention — have also been pushing Congress to stop compounders from making what drug companies consider copycat products.
Compounders say there are times they should be allowed to make products that are essentially copies — when manufactured products are unavailable because of drug shortages and when drugmakers have stopped producing a needed product.
Veterinary compounders and veterinarians are trying to block a push by drugmakers to require patient-specific prescriptions before a medication can be made. Matt Wilson, a partner at Animal Clinic Northview in Ohio, said this creates serious problems in emergency situations. For example, apomorphine is commonly used to induce vomiting in dogs when they have ingested a poison but it must be given within hours to save the pet.
“There are so many drugs that are back-ordered and unavailable. You can’t properly practice medicine if you don’t have these products in hand,” said Wilson, who uses Wedgewood Pharmacy, which is part of the lobbying effort.
Instead of measures that could limit mass production or bar compounds similar to commercial products, compounders are telling Congress they want more-rigorous safety standards for all compounding pharmacies.
The International Academy of Compounding Pharmacists, the industry’s largest trade group, is asking for federal and state legislation that would require compounders to adhere to guidelines that are currently voluntary. The guidelines run more than 400 pages long and were developed by pharmacists, doctors and nurses.
“We believe they need to be mandated by law,” said David G. Miller, IACP’s executive vice president.
Miller said he told congressional staffers that he still wants state inspectors to retain the authority to enforce the standards for most compounding pharmacists. Last month, Miller reversed course on his long-held position that all compounders should be regulated by state boards of pharmacy, saying manufacturing-style firms that market and sell products without patient-specific prescriptions should register with the FDA and be inspected by the agency.
The shift in IACP’s position followed a Washington Post investigation that showed 15 of the nation’s largest compounding pharmacies mass produce medications, often shipping them across state lines without patient prescriptions. The Post also reported that shoddy equipment and unsanitary conditions at some of these firms had caused patient illnesses and deaths long before this fall’s deadly outbreak but that the firms rarely were penalized.
IACP and other groups are squaring off over which pharmacies would fall into the new category and face stepped-up FDA enforcement.
Many compounding experts and drugmakers maintain that size is the key factor for defining this new category. Express Scripts, a company that has a compounding arm that makes fertility drugs, is telling Congress that even though it ships to all 50 states, it does not belong in this new group, since it makes medications for individual patients.
Among those most affected are large hospitals, which often compound medications in-house. They want to be excluded from increased federal scrutiny, arguing that they make drugs only for their individual patients.
Many smaller community hospitals do not have the resources to mix their own medications. If they cannot buy the medications from drug manufacturers, these hospitals often rely on large compounding pharmacies to supply pain medication, anesthetics, and drugs commonly used in labor and delivery. Lobbyists for smaller hospitals say they want more oversight of compounded products.
Alice R. Crites contributed to this report.