FDA’s manufacturing inspections questioned; generic approvals slow down

By PharmaCompass

2019-07-04

Impressions: 70 Article

In the US, the House Committee on Energy and Commerce (E&C) sent a letter to acting FDA Commissioner Ned Sharpless last week questioning the agency’s work overseas. The congressmen also sent a letter to the US Government and Accountability Office (GAO) asking for a review of FDA’s drug inspection program.

“We remain concerned about whether FDA has the resources, policies, management practices, and authorities to oversee adequately foreign drug manufacturing,” E&C chairman Frank Pallone, ranking member Greg Walden and other congressmen wrote.

They were particularly concerned about the sartan recalls, and sought the most recent FDA data on inspections and unredacted Form 483s and other reports from facilities linked to those recalls.

In the letter to GAO, the congressmen have sought a look into FDA’s high-risk inspection selection process, the quality of data FDA relies on to select establishments for inspection, as well as the number of foreign sites subject to inspection and the frequency with which FDA inspects such sites.

A recent report from the FDA’s Office of Pharmaceutical Quality showed that 70 percent of drug manufacturers registered with the agency in FY2018 were based in the US, India, China, South Korea and Germany.

“Recall rates have generally held steady over the past five years and appear specific to incidents,” FDA said, citing the high rate of sartan recalls linked to nitrosamine impurities in FY2018 and FY2019.

Meanwhile, generic drug approvals, which had hit an all-time high in 2018, hit a low last month.

In June, the FDA approved less than half the monthly median of 80 drugs recorded over nearly two years, since the agency began operating under a new generic user fee agreement in October 2017.

According to Raymond James analyst Elliot Wilbur, the downward slide “warrants careful scrutiny in the months ahead” and could hinder growth prospects for the generic industry.

The low approvals could be due to factors such as the FDA’s struggles in dealing with nitrosamine impurities, Wilbur said.

The PharmaCompass Newsletter – Sign Up, Stay Ahead

Feedback, help us to improve. Click here

Image Credit : #Phisper Infographic by SCORR MARKETING & PharmaCompass is licensed under CC BY 2.0

“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

NEWS

DRUGS & DEVELOPMENTS

MARKET INTEL by PharmaCompass