US FDA urges payers to look at drugmakers' quality records to prevent shortages
The US Food and Drug Administration (FDA) made the suggestion in a wide-ranging shortage mitigation plan issued last week in response to a 2011 executive order from President Barack Obama that called on it to do more to prevent disruptions to the country's drug supplies.
The idea is that encouraging hospitals, pharmacies and insurers to check if a supplier has received a Form 483 or warning letter will favour those manufacturers whose operations are compliant and pressure the entire industry to do more to improve quality.
“[The US] FDA makes certain information publicly available about manufacturers’ historical ability to produce quality products…Better use of this information could help incentivize manufacturers to focus on quality and, ultimately, prevent shortages.”
Root cause of shortages
Everything from a natural disaster to industry economics can disrupt drug supplies. However - according to the FDA - the vast majority of drug shortages (66% of the 117 recorded in 2012) are caused by manufacturing quality problems.
In the document the FDA argues part of the reason for these problems is a lack of manufacturing innovation and suggests that: “In many cases pharmaceutical manufacturing processes, facilities, and equipment lag behind innovation in drug development. Some processes and facilities have become outdated, resulting in quality problems that can lead to drug shortages.”
The agency adds that while it will continue to work with industry to encourage adoption of quality systems – as it must under FDASIA – “other stakeholders might explore economic, financial, or other means to incentivize innovation and new investments in manufacturing quality drugs.”
Specifically it suggests buying only from manufacturers with a history of good quality or including ‘failure to supply’ clauses in purchasing contracts “could further incentivize manufacturers to invest in quality improvements, and ultimately prevent drug shortages.”
Redundant capacity
Another suggestion made by the FDA is that manufacturers consider setting up redundant production plants, explaining that shortages are often exacerbated by just-in-time inventory practices and lack of capacity in the market.
The agency says that, while it cannot force drugmakers to add extra capacity, “Many stakeholders, including commenters to the Federal Register notice, have suggested that building redundancy, holding spare capacity, and increasing inventory levels could lower the risks of shortages.”
Publication of the FDA plan comes just a few weeks after German drugmaker Boehringer Ingelheim announced it will close contract manufacturing organisation (CMO) Ben Venue, which has been at the heart of a number of drug shortages in the last few years as a result of quality problems.
At the time the agency told in-Pharmatechnologist.com that “Ben Venue Laboratories informed FDA of its decision to close, and we are assessing the drug shortage impact of this closure. We remain committed to doing everything we can to address any drug shortages so that patients can get the medicines they need.
“We are working with other manufacturers making the drugs that are in shortage, or have the potential to go into shortage, to help them increase production if they are willing and able to do so.”
