The US Food and Drug Administration's (FDA) proposed quality metrics program is proving to be a bitter pill for the pharmaceutical industry to swallow.
Months after FDA revised its draft guidance in response to industry concerns, a consortium of industry groups, including the Association for Accessible Medicines (AAM, formerly GPhA), the Pharmaceutical Research and Manufacturers of America (PhRMA), International Society for Pharmaceutical Engineering (ISPE), Bulk Pharmaceuticals Task Force (BPTF) and the Pharma & Biopharma Outsourcing Association (PBOA) are asking FDA to halt its plans to move the program forward.
In comments submitted to the revised draft guidance, the consortium, along with the Biotechnology Innovation Organization (BIO) and a host of major pharmaceutical companies, including Allergan, Baxter, Celgene, Gilead, Sanofi and Teva, voice their concerns.
"After careful consideration and analysis with our member companies, PhRMA believes additional dialogue between FDA and industry and subsequent resolution of several fundamental issues are necessary before the FDA seeks to advance a quality metrics submission program," PhRMA writes.
Both BIO and AAM echo this sentiment, and PhRMA and AAM each say they believe the burden of the program as described in the revised draft guidance would outweigh its potential benefits.
In its comments, PhRMA says it still believes FDA is "substantially underestimating" the burden the program would impose, and AAM says the program "would require substantial resources, present significant operational challenges, and may draw resources and management attention away from other programs that are more important to patient health and safety."
AAM also appealed directly to the Office of Management and Budget (OMB) in a separate submission, saying it believes the program could cost industry up to $1.77 billion in the first year, with recurring annual costs of up to $1 billion.
Despite FDA reducing the number of metrics to be collected from seven (four mandatory and three voluntary) to three, PhRMA and AAM say the reporting burden is still high, as the number of data points used to calculate the metrics has gone up from 10 to 11.
"Moreover, the defined data elements and reporting structure are more specific and detailed than current [good manufacturing practice] GMP requirements," PhRMA writes.
PhRMA also says that FDA has been vague regarding the benefits to industry from participating in the quality metrics program, saying that FDA "has offered no additional information or specifics as to what benefits may be realized (e.g., expedited reviews, post-approval changes, or waiving pre-approval inspections under specific circumstances)."
Both PhRMA and BIO also say that FDA's plan to provide notice for opening its electronic portal for the quality metrics program 30-days prior to its launch is too short for companies to adequately prepare.
"Companies likely need to be preparing now to submit data in 2018," BIO writes, warning that the 30-day window could be even tighter if FDA were to make additional changes to its guidance in the interim.
BIO also raises questions about the process for shifting to mandatory quality metrics reporting. In its comments, BIO asks FDA to detail how it will evaluate the results of the voluntary phase, and asks for the agency to provide a clearer timeline for its plans to evaluate the voluntary phase and initiate notice and comment rulemaking.