Drug companies have ramped up lobbying efforts in Congress to force specialty pharmacies to either stop mass-producing drugs or face stricter regulation.
Commercial drug makers are also trying to prevent these specialty pharmacies, known as compounders, from making “knockoff” drugs for people and their pets that the companies say are costing them millions of dollars in annual profits, records and interviews show.
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 are pressing their interests.
Veterinary groups, for instance, are warning that any legislation requiring 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 last 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 websites 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 individual prescriptions 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.
Compounders 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.
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