Compounders, Lawmakers To Press FDA To Leave Office Use To States

An international group of compounders is working with lawmakers to draft a new letter asking FDA to rescind guidance requiring a patient-specific prescription for each drug compounded under 503A, and to return to states control over office-use compounding, saying the agency’s prohibition on such compounding runs against congressional intent. The call to rescind the guidance comes as President Donald Trump orders agency heads to improve efficiency by shifting functions to state or local governments.

John Voliva, executive vice president of the International Academy of Compounding Pharmacists, says the final guidance, “Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act,” put limits on office-use compounding that go against congressional intent and should be rescinded.

“We’re asking for FDA to rescind it. It would be administrative from that standpoint, and then issue a proposed rule through the [Administrative Procedure Act] so we have notice and comment from the stakeholders on the public docket,” Voliva said to Inside Health Policy.

IACP plans to support an upcoming letter spearheaded by Reps. Chris Stewart (R-UT) and Buddy Carter (R-GA), which is “very similar” to a bipartisan June 2016 letter spearheaded by Stewart and Rep. Henry Cuellar (D-TX), and signed by 61 lawmakers, to former FDA Commissioner Robert Califf, Voliva told IHP.

“We’re always talking with many offices on the Hill. We kicked the year off with Representative Buddy Carter and Representative Stewart, and we’re sending the FDA another letter about office use,” Voliva said to IHP.

The 2016 letter said FDA’s prohibition on office-use compounding goes against congressional intent. “Prior to the passage of the Drug Quality and Security Act (DQSA) of 2013, FDA circulated a draft Compliance Policy Guide (CPG) in 2012 to Congress that recognized office-use as legitimate and permissible and explained how compounding pharmacists can engage in office-use compounding before the receipt of a patient-specific prescription consistent with the provisions of 503A of the FDCA. The DQSA did not change the statutory language in 503A that was the basis of that CPG. During the consideration of the DQSA, six Members of Congress, on a bipartisan, bicameral basis, made statements in the Congressional record to clarify that the intent of the legislation was to preserve patient access to medications compounded for office-use. The Congress has been very clear with the FDA in its intent behind the DQSA as it relates to office-use compounding by 503A pharmacies. Unfortunately, the FDA has to date ignored that congressional intent and substituted the agency’s own, incorrect interpretation of the law in implementing and enforcing the DQSA,” the 2016 letter states.

However, a spokesperson for Carter told IHP the letter is on hold until a new FDA commissioner is confirmed, and declined to say how many additional lawmakers would sign onto the new letter.

The lawmakers may have an FDA commissioner willing to reexamine the balance between state and federal oversight of office-use compounding if nominee Scott Gottlieb is confirmed by Congress. Gottlieb, while acknowledging that safety challenges in the compounding industry may invite increased federal and state regulations, has said FDA should leave traditional pharmacy compounding when conducted by a licensed pharmacist compounding in response to a physician’s prescription for an individual patient to the states.

“When proper oversight demands that regulators examine the relationship between a provider and a patient (as proper oversight of the practice of pharmacy entails) then these endeavors are best left to state and professional authorities who have more proximity to the actual provision of care. Not every regulatory endeavor benefits from federal involvement,” Gottlieb testified to the House Energy & Commerce Committee in 2013.

But one expert disagrees, arguing such a move would actually be in violation of federal statute. A move to allow states to set their own requirements on office stock would blur regulatory oversight lines and would likely require a statutory change, according to Elizabeth Jungman, director of public health programs at The Pew Charitable Trusts.

“Federal statute requires that compounding be tied to a prescription, unless it occurs in an outsourcing facility, so changing that requirement would require a statutory change. FDA could alter how it interprets the statutory provision, or the emphasis it places on enforcement, but if FDA took the position that states get to set requirements on office stock (i.e. that they could permit compounding without a prescription other than in outsourcing facilities) that position would be subject to challenge as being in conflict with the statute. Also, there has been movement in many states to align with best practices for sterile compounding oversight, so any weakening of the federal posture would cause states to have to wrestle with ensuring accountability lines that are currently clear and in the interest of public health — a situation that would begin to look similar to the confusing regulatory environment that existed prior to the DQSA,” wrote Jungman in an email to IHP.

But, in an interview with IHP in January, Carter said that FDA’s restrictions on office-use compounding limit patients from getting needed medication and hurt patients. “Scope of practice should be something that each state’s board of pharmacy should do. That’s what should be decided by states and not the federal government. What the federal government is trying to do is to make all pharmacies into 503B pharmacies. What the FDA is doing, is that they are taking certain provisions in the 503B program and trying to put them into the 503A program,” Carter told IHP.

Mark Baum, CEO of Imprimis Pharmaceuticals, told IHP he supported limited office-use compounding. “I am an advocate for office use compounding but only for emergent issues where the patient needs help immediately. As a regular course of conduct, I am not an advocate for office use,” Baum said.

FDA drug center chief Janet Woodcock noted in a recent FDA podcast that compounding deaths occurred in 2016, but added FDA must balance its limited resources to contain injuries from pharmacy compounding and other agency obligations.

“And then finally, compounding–we can’t let up on that. We continue to have deaths and harm from compounding. We did in 2016, and we will probably continue to have that. But we have to work out a way that will not totally strain our resources and the field’s resources so we can conduct our other obligations, but at the same time manage to control any harm that would be coming from pharmacy compounding,” Woodcock said. — David Lim (