Nearly 40 years on, the generic drug market is often lauded as an American success story.

But a closer inspection reveals such back-patting ignores the potential for serious public health risks caused by ongoing shortages in the generic drug supply. It also ignores quality issues and lingering physician and patient doubts about generics, especially those made in other countries.

While the FDA has been warning about drug shortages for much of the past decade, not a lot has been done to address the root causes – other than to require manufacturers to report potential supply disruptions. As of Wednesday, 107 drugs were listed in short supply in the U.S.; the vast majority of those are generics.

That number is down from the 178 shortages reported in 2010 when the FDA began to sound the alarm about the rising number of prescription drug shortages, but the seriousness of the problem goes beyond the numbers, as several of the generics that currently are hard to come by are desperately needed to treat patients hospitalized with COVID-19.

Speaking at the FDA’s Generic Drugs Forum Wednesday, Michael Kopcha, director of the Office of Pharmaceutical Quality at the agency’s Center for Drug Evaluation and Research, said 63% of the drugs in shortage at any given time, on average, are generics. Exacerbating the problem is the fact that 61% of all generic drugs approved by the FDA are not being marketed.

In the COVID-19 context, a number of drugs that are in demand now were discontinued last year by at least one generic drug company. Other generics needed to treat COVID-19 patients have been in shortage for a few years. For example, cefepime, an antibiotic used to treat secondary infections, has been in short supply since 2015. A few generics, such as propofol and azithromycin, were added to the shortage list in the past week because of spikes in demand due to the pandemic.

Drug quality issues are by far the No. 1 reason for new drug shortages, according to Kopcha. Quality concerns, in turn, erode doctor and patient confidence in generic drugs. In a 2018 survey of 650 doctors in which they were asked about drug quality, nearly half the respondents said they always, often or sometimes write “dispense as written” prescriptions for brand drugs even when a generic is available. While 73% of those said they did so at the patient’s request, 16% said they “do not trust prescription generic drugs.”

Even more doctors questioned the quality of any drug made in other countries; 38% said they didn’t think drugs made outside the U.S. for the U.S. market adhered to the FDA’s manufacturing standards and regulations and 25% said they weren’t sure if foreign-produced drugs met agency standards. Consumers responding to a similar survey conducted by the FDA and WebMD shared those concerns.

Drug shortages feed the lack of confidence in generic drugs. More than one-third of the consumers responding to the WebMD survey reported having difficulty filling a prescription in the past three years due to a shortage. The survey found that consumers who had experienced a drug shortage first-hand were more likely to have used generic drugs and tended to rate drug quality lower than those who hadn’t faced a shortage, Kopcha said.

As FDA officials have in the past, Kopcha identified the root causes of shortages as:

  • a lack of incentives for manufacturers to produce generics, which are less profitable despite accounting for 90% of the prescriptions dispensed every year;
  • no market recognition or reward for manufacturers that have a mature quality management system that’s proactive and focuses on patient outcomes;
  • logistical and regulatory challenges that make it difficult to recover from supply disruptions.

As a solution, the FDA has suggested a quality rating system that would inform purchasers and patients about the quality management at drug manufacturing facilities. Such a system would bring transparency to the generic market and could potentially include the sources of active pharmaceutical ingredients used in the drugs, Kopcha said.

It also would give generic manufacturers with strong quality management systems a competitive edge that could support more sustainable pricing for generics, which would lead to fewer marketing discontinuations and shortages.

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