HHS Secretary Sylvia Burwell told House lawmakers Tuesday (March 15) that since neither a guidance nor a rule exists on office-use compounding, the practice should be able to occur, directly contradicting FDA's stance that traditional compounders must obtain patient-specific prescriptions.
FDA started a firestorm in 2014 when it laid out its stance in response to a bipartisan House inquiry on whether the agency would allow anticipatory compounding for physicians to use in their practice without having patient-specific prescriptions. Industry sources had seen signals from agency inspection trends on how FDA would treat office-use compounding, but were surprised when FDA's letter to lawmakers drew what some viewed as “a line in the sand."
Burwell sent a different signal this week. When Rep. Buddy Carter (R-GA) raised his concerns about FDA restrictions on compounding for office-use at a hearing held by the House Committee on Education and the Workforce, Burwell told him there is no guidance or rule preventing the practice. Carter said he is looking for guidance from FDA on the topic.
“We don’t have any guidance out preventing that, maybe I can follow up with your staff to understand…Right now compounding should be occurring and that there is not a problem in terms of any guidance or any rules about it right now,” said Burwell.
The International Academy of Compounding Pharmacists found the HHS secretary's remarks encouraging. Dagmar Anderson, vice president of communications for IACP, said the group has been arguing that office-use compounding is allowed by the Drug Quality and Security Act. In IACP’s white paper on the topic, the group says that “[b]ecause Congress only reinstated Section 503A, and did nothing to change any office-use provisions within 503A, FDA has recognized in the past that Section 503A allowed office-use. Thus, FDA’s prohibition of office-use has left a widely accepted industry practice encompassed in a cloud of uncertainty."
Meanwhile, key brand and generic industry groups are urging House and Senate appropriators to keep language out of the 2017 appropriations bill that “impedes FDA’s ability to enforce compounding law, including prescription and quality standard requirements.” Signers of the March 7 letter include the Biotechnology Innovation Organization, Generic Pharmaceutical Association, Pharmaceutical Research and Manufacturers of America, Pew Charitable Trusts, Trust for America’s Health and American Public Health Association.
The groups wrote: “Traditional pharmacies, primarily regulated by the states, should not produce supplies of compounded drugs without prescriptions, also known as “office stock” compounding. The quality standards applied to pharmacies are appropriate for traditional practice, but not for operations at a larger scale where more patients are exposed. These compounded office stock supplies may also sit on clinic shelves for an extended period of time, allowing any microbial contaminants to proliferate to harmful levels.”
The letter notes that appropriators included language in the report accompanying the FDA funding bill that directed FDA to issue a guidance document how compounding pharmacists can continue to engage in office-use compounding before the receipt of a patient-specific prescription.
FDA's interpretation of the Drug Quality and Security Act in restricting office-use compounding sparked a backlash from pharmacy and healthcare provider organizations, who pushed congressional health care committees at the end of 2014 to take legislative steps to stop FDA from requiring patient-specific prescriptions for office-use compounding, complaining the agency's approach is barring patient access to urgently-needed antibiotics and goes against congressional intent.
The agency's move also triggered Sen. David Vitter (R-LA) to introduce legislation last year that would put the practice of office-use compounding clearly under state regulation by exempting compounding pharmacies from new drug, current good manufacturing and adequate directions-for-use requirements if the drug is compounded and distributed to a practitioner as permitted by state law for use in the treatment of or administered to a patient of the practitioner.
Some stakeholders have also pushed broader use of compounding as a way to temporarily resolve drug pricing issues. Hospital and pharmacy stakeholders told the Senate Special Committee on Aging in December that Congress should make it easier for pharmacies to compound drugs subject to price gouging while FDA reviews generic applications for those drugs. However, Pew cautioned against the move, noting that compounded products do not meet the same approval standards as commercially available products. -- Erin Durkin (edurkin@iwpnews.com)
