- An inter-agency U.S. task force looking into drug shortages found "a broken marketplace" and issued a set of recommendations that includes creating a rating system for manufacturers.
- The number of drug shortages is on the rise, and the impact across the healthcare system "is likely underappreciated," the Food and Drug Administration said in an Oct. 29 news release.
- Medicines that fall into shortage are often relatively inexpensive and can become unprofitable for manufacturers, the FDA said. Creating a manufacturer ratings system might be one way to incentivize higher prices, the agency added.
Drug shortages, which have challenged the U.S. healthcare system in recent years, can put patients' lives at risk. The medicines in short supply range from EpiPen to vincristine, a crucial treatment in childhood cancer.
The FDA-led task force was clear in its report that there any many reasons for the shortages. It called for collecting more information to understand the practices that contribute to the problem and the impact it's having.
Still, the rating system for manufacturers would address one key aspect of the broken marketplace, the FDA said. Manufacturers who have gone beyond basic requirements and have a "mature" quality management system are more likely to have reliable production, and purchasers who can identify these manufacturers through ratings may be willing to pay more for their drugs, the FDA said.
"You might not always shop based solely on the lowest price," Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a post on the agency’s website. "For instance, if you highly value your time, you may choose a car from a manufacturer with a great reputation for reliability, even though similar cars cost a bit less."
The task force also advocated new approaches to contracts that might include financial incentives to make steady production of critical drugs worthwhile for drugmakers. Purchasers could pay higher prices for medications made at top-rated facilities or require a certain rating before entering a contract.
International harmonization can also help, the FDA said. Companies are increasingly producing medicines in different countries, which can make tackling regulatory hurdles harder. A guideline for "regulatory flexibility" could help avoid supply disruptions, the agency said.
"The types of enduring solutions proposed here will require multi-stakeholder efforts and rethinking of business practices throughout the health care system," the task force said in its report.
In a statement, the Association for Accessible Medicines pledged to work with the FDA to address the issue of drug shortages. It also applauded the agency for recognizing that "deteriorating market conditions have led to sustainability issues in the manufacture of certain medicines."