As the end of the year is approaching and plans are made for next year, it is important to be aware of the current strategy and budget of the FDA. The past five years have revealed a continuous decline in injunctions, warning letters and inspections from the FDA. The projections for 2010, however, clearly reveal an agency that plans to increase enforcement.

Over $3.2 billion has been requested for the FDA, a net program level increase of $511 million over 2009. This is the largest increase ever requested for FDA. This funding will be earmarked to support the enforcement of the regulations.

The FDA’s stricter enforcement campaign is picking up pace. In May 2009, KV Pharmaceuticals entered into Consent Decree four weeks after an inspection due to a failure to meet GMP requirements. In June 2009, products were seized at Caraco Pharmaceuticals six weeks after an inspection because they were not compliant with current GMPs.

Industry should take note of the following trends and steps taken by the FDA:

• The FDA has been aggressively recruiting and has hired over 400 new investigators.
• After being hired in April 2009, the previously acting FDA Deputy Commissioner Joshua Sharfstein set an assertive tone, prompting a large spike in warning letters. (There has been a 47% increase in warning and untitled letters to pharmaceutical companies from last year at this point.) He said that companies that purposely adulterate products will be criminally prosecuted.
• The new FDA Commissioner, Dr. Margaret Hamburg, has announced six, new, aggressive enforcement procedures, stating that, “the FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible.” (These specific policies will be discussed in a later blog.)
• The controversial practice of having all draft Warning Letters reviewed by the Office of the Chief Counsel (OCC) has been discontinued. This policy had caused a 60% decrease in warning letters.
• Legislation introduced in April would authorize FDA to collect inspection fees from companies and to issue subpoenas or detain products when inspectors believe a product is adulterated or misbranded.
• FDA is increasing international inspections and collaborative enforcement efforts.
• FDA warning letters and injunctions are frequently linking GMP problems with the manufacturing of products that do not have the required new drug approval or do not meet OTC monograph standards.
• The agency is continuing to crack down on various types of unapproved drugs.
• Regulators are looking for a deeper understanding of the flaws in the quality system and are focusing on quality system, manufacturing, and product nonconformances.

What can we expect in 2010 from the FDA?
As the new policies are put into place and the momentum continues with the current trends, we can expect the following from the FDA in 2010:
• More warning letters
• More inspections
• More injunctions
• Possible inspection fees, subpoenas and detained products

More than ever, companies need to ensure that that their 483 responses directly address all of FDA’s concerns and provide firm commitments to thorough corrective actions. Just as importantly, they must be proactive in analyzing and constantly improving their quality possesses in order to meet the highest standards of current Good Manufacturing Practices. As always…
• Do What You Say, Say What You Do
• Reflect Reality
• Quality Product is Born of a Quality Process*

* © Coda Corp USA 2009. All rights reserved.

Corrine R. Knight
Quality Associate
Coda Corp USA
(p) 814.839.4727
[email protected]
Web Page
Robert F. Church and Michael N. Druckman. (2009) Recent Trends in FDA’s Pharmaceutical GMP and GCP Enforcement
Web Page
Bob Dana (2009) IG Briefing: Inspection Trends/Regulatory Affairs Interest Group Reviews FDA Inspection Findings
Web Page
(2009) Fiscal Year 2010 Budget in Brief
Web Page
Lisa Baird (2009) FDA Commissioner Announces Aggressive New Enforcement Policy
Web Page
(2009) Questions and Answers about Caraco Drugs
Web Page
(2009) KV Pharmaceutical enters into decree with FDA

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