FDA’s McMullen: No Bigger Waste Than Drug Shortages Due To Data Integrity

FDA officials highlight at a recent summit in India recurring issues around drug manufacturing compliance including microbial contamination and data integrity concerns but emphasize that the agency isn’t in a “gotcha” mode for companies.

From L-R: Shirish Belapure - Senior Technical Advisor, IPA; Rubina Bose, Deputy Drugs Controller India; Sarah McMullen, Country Director, India Office, US FDA; James Pound, Deputy Director Standards & Compliance, MHRA; Thomas Hecker, Inspector, Certification of Substances Department, EDQM

Regulators, pharma and other key stakeholders discussed a host of burning issues around inspections and quality systems at a recent summit in India, including the need for senior management oversight of facilities to ensure “sustainable compliance.”

Shortages Getting More Complex

Patrizia Cavazzoni, director of the US FDA's Center for Drug Evaluation and Research, noted that depending on the precipitating events, some drug shortages can endure for months to years - for instance plant remediations and agency approvals.

Over 60% of shortages are largely due to product quality problems at the manufacturing level. Some of the shortages are more complex, tend to last longer and are also more challenging and take more effort to mitigate, Cavazzoni said.

On cisplatin shortages in the US, she stated that a firm that was responsible for over 50% of cisplatin supply had some major quality issues and decided to shut down production, leading to the current shortfall.

“In addition, the shortages of cisplatin led to a ripple effect as demand for the second-line treatment carboplatin increased, but the manufacturers were unable to meet demand,” she added. 

Referring to an overall gap in manufacturing capacity for critical drugs in the US and globally, particularly for sterile injectable drugs, Cavazzoni also pointed to some “deeply rooted economic reasons” for this shortfall, which include the lack of incentives currently for generic manufacturers to manufacture products over the market demand, so that “we have the safety buffer in case some disruptions in the supply chain were to happen.”

This can lead to supply disruptions, which can ultimately result in shortages. Disruptions can be caused by unforeseen events including “geopolitical concerns” or financial pressures could lead to manufacturing site closures/firm bankruptcies.

Other experts have in the recent past highlighted the declining return on invested capital for the 24 top manufacturers in the US generic drug market. Data from S&P’s Capital IQ indicated that the median return fell from 13% in 2015 to 5% in 2022. (Also see "Why Generic Drug Manufacturing Is Faltering And Ways To Bolster It" - Pink Sheet, 2 June, 2023.)

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA

Pink Sheet Podcast: CBER Director’s Political Spin On COVID-19 Vaccines And US FDA RIFs Finalized

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad using an unproven theory to help explain his COVID-19 vaccine decisions and the impact of the recently finalized reduction-in-force at the FDA.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.

Access Risks Loom For All Drugmakers With Fourth Circuit Mifepristone Decision

 

The FDA law establishing REMS authority does not preempt a West Virginia law that would restrict mifepristone use in the state, an appeals court said, a decision that could have broader ramifications for the agency’s authority to ensure drug access.

US FDA’s Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming

 

The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.

More from Agency Leadership

Access Risks Loom For All Drugmakers With Fourth Circuit Mifepristone Decision

 

The FDA law establishing REMS authority does not preempt a West Virginia law that would restrict mifepristone use in the state, an appeals court said, a decision that could have broader ramifications for the agency’s authority to ensure drug access.

US FDA’s Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming

 

The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.

Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 

Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.