Industry groups spar over FDA’s proposed compounding survey

The Outsourcing Facilities Association (OFA) has called for more transparency in US Food and Drug Administration (FDA) inspections and in the development of the 503B bulk drug substances list, which lists drugs substances for which there is or isn’t a clinical need for compounding. The Pharmaceutical Research and Manufacturers of America (PhRMA), on the other hand, urged greater FDA oversight of compounding by outsourcing facilities.

The comments were made in response to a recent Federal Register notice on a future survey proposed by the FDA’s Compounding Center for Excellence examining the challenges and opportunities for outsourcing facilities and to help FDA identify knowledge and information gaps and operational barriers and to help guide future decisions.

The notice was published under the Paperwork Reduction Act of 1995 (PRA) which requires federal agencies to submit to the OMB each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. The deadline for submitting comments was 4 November.

In its comment, OFA said it “appreciates FDA’s interest in developing a comprehensive understanding of the outsourcing facility sector, its challenges, and opportunities for advancement.”

Yet the group “urges the FDA to take stakeholder feedback into account when formulating its information collection activities.”

In its survey, OFA proposed an additional 21 questions, with several of these questions relating to inspections and FDA’s development if its 503B bulks drug list. FDA’s proposed survey had ten questions.

The additional questions flag OFA’s continuing concerns with FDA’s policies for drug compounders. Some of the additional questions are:

How can FDA increase transparency with inspections?
What is your experience with the development of the 503B bulk list?
How can FDA improve the development of the 503B bulk list?
What percentage of your operations are compounding from bulk versus compounding from finished dosage form?
What are the research and development costs associated with a 503B preparing to produce a compounded drug product?
If a drug is removed from the drug shortage list, how long should outsourcing facilities be able to sell existing inventory?
How much does it cost to perform the testing required under [current good manufacturing practice] cGMP?
If a drug is added to the drug shortage list, how long will it take until to fill orders using bulk drug substances to compound the product?
How can FDA publicly identify outsourcing facilities that are compliant with regulations from those that are non-compliant?

The group stated that the “questions and clarifications may better inform FDA of the challenges and opportunities outsourcing facilities face.”

With respect to inspections, OFA said “there are a number of firms that have inspections that remain open after multiple years. Many of these include firms that are operating under a warning letter or additional actions … We further believe that closure of inspections in the form of published FMD [Field Management Directive] letters and EIRs [Establishment Inspection Reports] that are discoverable via [the Freedom of Information Act] FOIA, provides direct feedback to the industry and the transparency of such will also signal consistent enforcement of CGMP standards.”

OFA also wants more transparency in the development of FDA’s bulks drug list. “To date, FDA has identified there is a clinical need to compound from bulk only five substances. The interim list of category 1, category 2, and category 3 is not updated consistently, as FDA expressed in guidance. Additionally, OFA believes there could be more transparency as to the review process.”

FDA periodically updates its list of active pharmaceutical ingredients that outsourcing facilities can use in drug compounding under section 503B of the Federal Food, Drug, and Cosmetic Act, to help ensure access to compounded medicines when it’s been determined that there is a clinical need.

PhRMA calls for stricter oversight of drug compounding

In its comments, the PhRMA pushed back on recent advents in the compounded drug industry, writing that some outsourcing facilities “are entering into new and unanticipated commercial arrangements with telehealth companies to engage in aggressive nationwide advertising. To meet the extensive market that they and their partners are generating, outsourcing facilities must compound more drugs faster than ever, making mistakes and adverse events associated with compounded drugs all the more concerning.”

The group added that this exceeds congressional intent and called for FDA to “stop outsourcing facilities from behaving like conventional drug manufacturers.”

PhRMA also took aim at some of the questions FDA proposed in the Federal Register notice, stating that several of the questions pertain to “financial considerations and economic consequences outside of FDA’s public health mission.”

Additionally, PhRMA suggested FDA “pose more probative questions to obtain information on how outsourcing facilities comply with regulatory and quality frameworks designed to prevent them from transforming into conventional manufacturers and to avoid distribution of unsafe, ineffective, and poor quality compounded drugs.” In that vein, the group recommended FDA ask an additional eight questions centered on safety and compliance issues related to outsourcing facilities’ operations.

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Industry groups spar over FDA’s proposed compounding survey

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