Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Drug companies are ramping up efforts on Capitol Hill to block specialty pharmacies from mass producing drugs in lightly regulated conditions, urging lawmakers to require that these enterprises return to their traditional roles or face stricter standards.
Commercial drug makers are also pressing a lobbying campaign aimed at stopping 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 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.