With drug shortages happening more frequently, the Food and Drug Administration wanted to get to the bottom of it.
An FDA task force released a report on Wednesday that delved into the cause of drug shortages and outlined steps to prevent future problems. The report found that the drugs most likely to experience shortages were “financially unattractive drugs” and more likely to be sterile injectables.
The task force also found that drugmakers often stopped manufacturing a drug for commercial or financial reasons shortly before a shortage. Prices rarely rose once a shortage began, indicating that the market did not respond like it normally would to lower supply, according to the report.
The findings laid out three areas to prevent future drug shortages.
The FDA wants to help manufacturers and the public better understand the impact of shortages. For one, it proposed doing more comprehensive research on the effects on health outcomes from a drug shortage. The report also determined that the agency should better characterize shortages to include information like frequency, persistence, intensity of the shortage and the impact on other available treatments. The FDA also wants manufacturers to be more transparent about their supply contracts.
The FDA would also begin to rate manufacturers on the maturity of their quality-management systems and provide incentives to companies with high ratings. The task force said pharma companies could disclose these ratings to give them a competitive edge in the market and bring more transparency to the manufacturing process.
Finally, the FDA recommended urging companies to continue making these low-cost drugs with financial incentives. It also may reward companies with high quality-management ratings by paying more for their products or guaranteeing to purchase products from that facility.
