US-manufactured brand pharmaceuticals viewed as higher quality: FDA

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Erin McCallister Senior Manager, Health Research Institute, PwC US February 21, 2020

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Providers and consumers expressed a desire for greater transparency on the drug supply chain at a meeting co-hosted by the FDA and the Duke-Margolis Center for Health Policy. At the Feb. 3 meeting, the FDA presented the results from a drug quality survey which found that consumers and physicians associated higher quality with brand-name drugs and were uncertain about the safety of drugs manufactured outside the US.

The survey asked 3,037 WebMD visitors and 650 physicians about their perceptions of prescription pharmaceutical drug quality and found that both groups believed branded prescriptions to be of the highest quality. Ninety-one percent of physicians and 75% of patients said the quality of these drugs was good or excellent. By comparison, 77% of physicians and 70% of patients ranked generic prescription drugs as high.

Both groups seemed to question the quality of imported drugs. Nearly three-quarters of respondents—physicians and consumers—were either uncertain or didn’t believe that drugs manufactured outside the US adhered to FDA manufacturing quality standards and regulations.

“The information that’s available to us [about the drug supply chain] is not adequate and not transparent enough,” said Michael Ganio at the meeting. Ganio is director of pharmacy practice and quality at the American Society of Health-System Pharmacists.

The FDA survey also showed that both groups were swayed by advertisements when it came to assessing drug quality. Twenty-three percent of physicians and 32% of consumers associated advertisements with higher quality drugs.

Additionally, specialists, such as cardiologists and endocrinologists, were more likely to associate the brand drug with higher quality (63%) than primary doctors (54%).

HRI impact analysis

The FDA has made efforts in recent years to modernize and increase the transparency of its drug quality assessments. In 2015 it launched the Office of Pharmaceutical Quality, and OPQ’s 2019 annual report, issued on Feb. 10, touts some of the progress the office has made over the past five years, including the significant increase of generic drug approvals in 2019 compared with 2015 (1,014 vs. 726).

In the report, the FDA said that “the quality of a drug cannot be judged solely on where it is made and whether it is brand name or generic,” and highlighted that 72% of manufacturing facilities for active ingredients used in drugs are located outside the US.

According to the FDA, there are 2,278 foreign manufacturing sites subject to inspection, with 347 sites in China (15%) and 476 sites in India (21%). However, facilities in China and India were also found to have a lower rate of “acceptable final outcomes” upon FDA inspection, with 90% and 83%, respectively, compared with 98% for facilities in the European Union and 93% for US sites.

In an October report, the FDA’s Drug Shortages Task Force recommended a rating system that would inform consumers and other purchasers about the quality of the manufacturing facility from which the drug was produced. The group found that 62% of drug shortages were due to quality issues.

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

Erin McCallister

Senior Manager, Health Research Institute, PwC US

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