PhRMA And BIO Seek Changes In FDA’s Guidance To Mitigate Drug Shortages

Last month, several pharma advocacy groups voiced both their approval and concerns with the FDA’s draft guidance concerning how to handle potential drug shortages. The draft was intended to help companies form and commit to risk management plans (RMPs) to assist with any shortages of drugs or biologics products.

While groups such as Civica and The Biosimilars Forum offered comments to the FDA to change the guidance, other groups are letting the FDA know its concerns.

The Pharmaceutical Research and Manufacturers of America (PhRMA) submitted comments to the FDA initially appreciating the FDA’s efforts in establishing a framework but feeling that the guidance needs to be changed.

PhRMA recommends that the FDA update the guidance to reflect recent changes around terminology and that the FDA use a risk-based approach to revise the RMPs instead of an annual basis that is laid out in the draft.

The lobbying group also recommends that the FDA update its guidance to acknowledge that existing “Pharmaceutical Quality System” processes that are used to maintain a state of control and drive continuous improvement could be used to support the RMP and RMP review process, where appropriate.

PhRMA notes that RMPs for similarly situated products may cross-reference or use overlapping concepts. The organization uses the example of products that source the same raw materials from the same facility, which can use the same risk mitigation approaches. It also encouraged the FDA to expand upon how the regulator will use information included in RMPs to inform its surveillance, including its approach to inspections.

The advocacy group also encourages the FDA to address how it will use RMPs in other related initiatives and to revise the guidance to acknowledge that the scope of the RMP’s authority is limited to a particular stakeholder.

“PhRMA appreciates the work FDA has done in helping to prevent and mitigate drug shortages, including in working collaboratively with industry. The draft guidance largely complements ongoing industry efforts to mitigate risk by having continuity plans in place to address supply chain or other disruptions,” PhRMA writes.

The Biotechnology Innovation Organization, or BIO, has also taken umbrage at some of the language and the timing of the draft guidance.

BIO’s initial comment states that the guidance using terms such as “primary stakeholder,” “secondary stakeholder” and “other stakeholder” to describe manufacturers is a broad definition. BIO noted that it could be interpreted that manufacturers of any step in the active API or drug manufacturing process need to have RMPs and is asking for clarification.

“Such a requirement would be highly burdensome to manufacturers of API intermediates or drug product intermediates and could be non-value added since manufacturers of intermediates might not have knowledge of the information needed to provide a meaningful RMP,” the comment says.

The BIO comment also notes that neither the draft guideline nor the Federal Register notice provides a timeline for implementing the final guidance and that manufacturers have had little direction on how to prepare. BIO is requesting that a period of at least two years from the publication of a final guideline before the FDA reviews RMPs should be implemented.

With the guidance using the term API, which usually applies to small molecule drugs, BIO commented that the FDA should clarify the scope of the guideline to include biologics and vaccines as well as replace API with “drug substance.” The organization also wants the FDA to specify what products specifically must have RMPs.

BIO’s comment also states that having two-way communication between contract manufacturing organizations can be more beneficial.

In November of 1937, editors from JAMA magazine penned a scathing letter about the United States’ inability to protect patients from toxins that masquerade as therapeutics, saying the drug development process was in dire need of laws with “common scientific decency.” In the preceding months, the nation had been riveted by the sudden deaths of nearly 100 people after taking elixir sulfanilamide. According to a congressional report, the elixir had been given to patients despite having only been “tested for its flavor but not its effect on human life.” Up until this point, drug manufacturers were not required to test therapeutics before sending them to market.

Seven years ago, Jay Bradner left high-profile posts at Harvard Med and Dana-Farber and jumped to the leadership role at Novartis’ global research arm, the storied Novartis Institutes for BioMedical Research, where one of his first jobs was reorganizing the group and cutting staff. And today we learned that he’s wrapping up his stint at the pharma giant in the midst of a major shakeup that forced development chief John Tsai out.