“Given the tragedy we've seen with NECC and the other concerns, our hospitals are very concerned about the safety of the medications that have been compounded by outsourcing pharmacies,” says Roslyne Schulman, director of policy development at the American Hospital Association.
Most experts agree that legislation is needed to reframe the regulatory oversight of the large-scale compounders that are more likely to take on high-risk sterile compounding. There is little data available about the size of the U.S. compounding market or the number of companies that are involved with high-risk sterile compounding. The International Academy of Compounding Pharmacists has estimated that the compounding industry accounts for up to 3% of the $300 billion prescription drug market.
The FDA has oversight of drug manufacturing, while states are responsible for regulating pharmacies. The oversight of large-scale compounders that ship across state lines tends to fall somewhere in between.
In the past year, lawmakers have spent countless hours in hearings, scheduling meetings and drafting legislation that they say will fill in the regulatory gaps that exist. Just last week, lawmakers announced a bipartisan, bicameral bill that they say will strengthen oversight of large-scale compounders. However, unlike the House and Senate versions that were previously introduced, the legislation makes registering as a compounder under FDA oversight voluntary.
The FDA, which has called for Congress to give it more authority to regulate large-scale compounders, rapidly stepped up enforcement within months of the outbreak, launching unannounced inspections of at least 50 compounding pharmacies producing “high-risk” sterile compounded drugs.
“For years, the FDA has conducted for-cause inspections of compounding pharmacies based on reports of adverse events,” an FDA spokesman said in an e-mail. “The agency took a more proactive approach by inspecting sterility practices at compounding pharmacies that may pose higher risks, including many with which the FDA has had issues in the past.”
During tense hearings last spring on Capitol Hill, some lawmakers argued that the FDA already had the regulatory oversight it needed over large-scale compounding pharmacies. The Government Accountability Office in July recommended that Congress clarify the FDA's authority over drug compounding.
Stepped-up inspections led to results. Fourteen compounders that operate in multiple states have issued voluntary recalls this year through the FDA, with the majority focusing on sterile injectable drugs. The U.S. District Court for New Jersey later entered into a consent decree with one of the compounders, Med Prep Consulting, enjoining the company from shipping contaminated sterile injectable drugs across state lines. At least three other compounders have also recalled products.
The Pew Charitable Trusts said it supports the legislation but has some concerns. “Because it's voluntary, it's not going to create a sweeping change immediately in how these facilities operate,” says Allan Coukell, Pew's senior director of drugs and medical devices.
The legislative process has generated interest from a wide variety of organizations. The new Working Group on Pharmaceutical Safety has spent $70,000 since June. The International Academy of Compounding Pharmacists has spent $390,000 on lobbying so far this year, more than three times than what it spent in 2011.
The bill would likely create a market where hospitals and clinics choose to buy drugs from registered compounders because they would be expected to have higher standards, Coukell says.
And many hospitals and healthcare providers continue to rely on outsourced compounding pharmacies. HHS' inspector general's office said 92% of the hospitals it surveyed use compounded sterile drugs and 77% have purchased some of the compounded medications from at least one outsourced pharmacy.