US Facilities Were Issued The Most Warning Letters By FDA This Year

US facilities were issued the most warning letters by FDA this year

The pharmaceutical industry, as well as consumers, have been feeling the heat of the recent compliance problems at drug companies across Asia.

Take the case of Semler Research as a case in point. In April this year, the US Food and Drug Administration (FDA) informed drug companies about data integrity concerns at Semler Research in Bangalore, India. The FDA also asked drug firms to repeat certain bioavailability/bioequivalence studies undertaken by Semler, as studies submitted from this CRO (contract research organization) were no longer acceptable.

The European Medicines Agency (EMA) followed the FDA and announced that bioequivalence studies performed at Semler’s India site cannot be used to support the approval of medicines in Europe.

This is clearly an era of regulatory action, where FDA warning letters, import alerts, drug recalls and non-compliance reports are becoming commonplace.

Rising instances of regulatory action

Last week, the EMA published a list of medicines recommended for suspension . This list came just weeks after a similar list was shared for studies conducted at Alkem Laboratories site in Taloja, India.

The recent announcement by the EMA was followed by a Bloomberg article that highlighted the dependence of the United States on Zhejiang Hisun, the manufacturer in China where “broad data manipulation” was uncovered by the FDA investigators.

The dependence on Hisun was such that the FDA had to allow the plant to continue exporting about 15 ingredients for use in finished drugs in the US, including nine key cancer medicine components.

The recently published annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) stated that 18 percent of the facilities inspected by the EDQM were found non-compliant with Good Manufacturing Practices (GMP).

How is the pharmaceutical industry gearing up for this era of regulatory action? At PharmaCompass we strive to provide free-access to information in order to help industry professionals take more informed decisions.

As a follow up to our compilation of non-compliance reports issued by the American and European regulators, published on this website in December 2015, this week we share our mid-year compilation for 2016. Here are some key highlights:

Click here to access the compilation of non-compliances (Excel version available) for FREE!

A surge in import alerts

In the past, compliance problems were usually associated with companies getting warning letters from the FDA. Import alerts seldom outnumbered the warning letters issued by the American regulator.

However, in 2016, a record number of companies were placed on FDA’s import alert list. Refusal of companies to be inspected by the FDA, failure to pay the GDUFA fees along with companies who did not meet GMP standards were all reasons why 35 different facilities were placed on the FDA’s Red List.

The enforcement is part of the FDA’s crackdown in recent years on manufacturing facilities that consistently fail to meet the agency’s standards. Many facilities that have come under scrutiny in the past year are located across Asia, with the majority in China and India.

While 23 facilities in China and eight in India dominated the list, Teva’s largest sterile injectable plant in Hungary was also placed on import alert.

The Generic Drug User Fee Amendments of 2012 (GDUFA) regulation in the US requires companies to pay user fees to supplement the cost of reviewing generic drug applications and for inspecting their facilities. This law is aimed at speeding access to safe and effective generic drugs to the public and reducing costs for the industry.

For the first time, the FDA has placed four Chinese and Indian generic drug facilities on the ‘Red List’ that bans them from shipping products to the US for failing to pay required GDUFA fees.

Click here to access the compilation of non-compliances (Excel version available) for FREE!

Warning letters not limited to Asia

This year, while the FDA has (so far) issued 23 warning letters pertaining to cGMP concerns, it may surprise some that the majority (10) were issued to facilities in the United States. Companies in India have received five warning letters, while four facilities in China failed to convince FDA investigators that their manufacturing systems were in compliance.

In addition to the facilities in the United States, warning letters were issued to SmithKline Beecham (GSK), Corden Pharma and BBT Biotech in Europe.

The pace at which European regulators have been uncovering GMP compliance concerns has been similar to that of the US regulator – European regulators have issued 23 notices of non-compliance so far and facilities in India and China account for a little over half of them.

Inspections conducted by European inspectors also found facilities out of compliance in France, Romania, Sweden, Germany, Spain and the United States.

Click here to access the compilation of non-compliances (Excel version available) for FREE!

Indian companies are fixing issues

While compliance problems have been dominating news headlines, major Indian manufacturers have started announcing receipt of Establishment Inspection Reports (EIRs) from the FDA. An EIR indicates the organization has successfully addressed some, if not all, of the compliance concerns. Companies like Wockhardt, Zydus Cadila and Lupin have announced receipt of EIRs from the FDA.

Other major Indian manufacturers, who have not been in the news due to compliance issues like Alembic, Granules India, Strides Shasun, Divi’s Laboratories, Suven and Claris LifeSciences also announced successful FDA inspections at their facilities.

Our view

The industry is experiencing significant turbulence due to compliance concerns that have been emerging for some time now. Sourcing and quality professionals need to adapt strategies to ensure their organizations engage with compliant manufacturers. Moreover, buyer-seller relationships need to evaluate how to ensure long-term sustainability in the supply of drugs.

PharmaCompass’ compilation of all the FDA warning letters, import alerts and EDQM non-compliance reports issued until mid-2016 is an easy way to evaluate companies that have run into compliance challenges so that appropriate risk mitigation strategies can be adopted.

Click here to access the compilation of non-compliances (Excel version available) for FREE!

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Image Credit : Surprise by Hartwig HKD 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.”

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