Drug Quality: FDA Officials Discuss Perceptions

Regulatory NewsRegulatory News | 03 February 2020 |  By 

Understanding how physicians, patients and industry perceive drug quality can help the US Food and Drug Administration (FDA) create new programs and address certain issues and needs, officials said Monday at an event on pharmaceutical quality at the National Press Club in Washington, D.C.

At the forefront of the issues around quality is the fact that, as an FDA report from last October showed, 60% of drug shortages are due to quality issues.

To try to better incentivize manufacturers to improve their quality, FDA is planning to set up a rating system that will use a set of attributes to allow stakeholders to differentiate which products manufactured in a facility go beyond basic quality systems, Patrizia Cavazzoni, deputy director for operations at FDA’s Center for Drug Evaluation and Research (CDER), said.

She said purchasers, payers, hospitals and patients would have more transparency on the facilities with such a system.


Michael Kopcha, director of FDA’s Office of Pharmaceutical Quality (OPQ), also noted how the agency is still working to obtain input on how such a rating system would work.

A comment from the audience suggested that FDA should score the quality of products, rather than facilities, because many do not know what products each facility makes and because many products’ different parts (active pharmaceutical ingredients, etc.) come from multiple facilities. Kopcha said the agency is struggling with whether to rate facilities or products and that there has been some pushback on providing ratings at the product level. He also said there is proprietary information that must be withheld in some circumstances.

Adam Fisher, acting associate director of communications at OPQ, also presented the findings of two FDA surveys on quality perceptions, one in collaboration with WebMD from 2018 with over 3,000 consumers and one with 650 physicians via email invite.

The survey’s results show how both physicians and consumers doubted that drugs manufactured outside the US adhere to strict regulations and standards set by FDA.


In addition, almost half of the physicians surveyed (47%) said they either always, often or sometimes write “dispense as written” on a prescription when a generic drug is available. And of those, almost three-quarters said they wrote “dispense as written” because a patient had requested it.


Both physicians and consumers questioned the quality of drugs produced outside the US, and many consumers did not know that FDA does not manufacture drugs or set drug prices.


Martin Van Trieste, president and CEO of nonprofit generic drug manufacturer Civica, also said at the meeting that he thought FDA was downplaying the number of poor manufacturing facilities in China.

“I’ve been there and you cannot tell me the Chinese product is as good a product as in the US or Europe. I wouldn’t buy a product made in China unless I have no choice. If we don’t fix what’s going on in China and India, the consumers are going to lose confidence in the medical system – we can’t put our heads in the sand on what’s going on outside the US and EU,” he said.

Trieste also noted that for his company’s medicines, they will print the manufacturer on the label, and on its website the API facility will be disclosed. And he noted that this kind of transparency on drug labels will only be achieved across the board if legislation is passed.

Understanding How the Public Perceives and Values Pharmaceutical Quality


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