Saturday, July 24, 2010

FDA Leverages Corporate Responsibility for GMP Compliance

The response by the FDA to the GMP violations at McNeil Consumer Healthcare represents a revitalized, but often-unheeded trend. This trend has two salient earmarks: (1) remind corporate officials of their responsibility, and (2) expand inspections to other facilities in the corporate network.

In the case of McNeil Consumer Healthcare, its parent corporation Johnson and Johnson was lectured on corporate responsibility in a January 15, 2010 Warning Letter concerning Tylenol problems:

“Corporate management has the responsibility to ensure the quality, safety and integrity of its products. Neither upper management at J&J nor at McNeil Consumer Healthcare assured timely investigation and resolution of the issues.”

Then, it is no surprise that the FDA inspected the J&J Lancaster, PA facility to see if more than the McNeil brands of Tylenol, Motrin, Zertec and Benadryl had problems.

And more problems they found. This time with J&J OTC brands: Mylanta, Pepcid and Imodium.

In another recent example, the FDA issued a Warning Letter to Apotex (March 29, 2010) after concluding an inspection of their Toronto facility. Again, the Agency pointed to corporate responsibility:

“…inspection uncovered several violations that are identical to those found during a December 10 – 19, 2008 inspection of your Etobiocoke, Canada site that resulted in the issuance of a Warning Letter to the Etobiocoke site in June 2009. These identical CGMP violations demonstrated a lack of adequate process controls and raised serious questions regarding your corporation’s quality and production systems.”

I say “revitalized” response since a broader, corporate view by the Agency is not really new. Perhaps it’s just juicing up a bit more under the new administration and the consumer advocate-turned FDA bulldog Joshua Sharfstein, principal deputy commissioner.

For example, in 2007 there was the Abbott Laboratories Warning Letter (March 13, 2007) that pointed to their need to apply corrective actions globally:

“Although the Agency recognizes your firm’s commitment to improving product quality and compliance with the Quality System Regulation, the Agency is not satisfied with the pace and results of your firm’s past corrective actions as they have not been effectively, timely and globally implemented..."

And in 2006, Boston Scientific was issued a Warning Letter (January 25, 2006) covering three sites, but the FDA reiterated in that letter their awareness of issues at three additional sites from previous inspections:

“The purpose of this letter is to apprise top management of your inadequate corporate-wide corrective action plan as evidenced by the continuing serious deficiencies identified at each of these facilities and to remind you of your responsibility to ensure all facilities continuously comply with the Act and all pertinent regulations.”

The purpose of this FDA strategic direction can be summed up in one word: “leverage.”

Similar to Archimedes’ lever, the FDA recognizes that in order to move the earth it needs a lever long enough and a fulcrum on which to place it. Thus the strategy is to place the long lever of enforcement action on the fulcrum of corporate officers.

It’s not as though the industry has not had sufficient warning. In her address in 2009 to the Food and Drug Law Institute, Dr. Margaret Hamburg, M.D., Commissioner of Food and Drugs, said:

“The FDA will no longer issue multiple warning letters to noncompliant firms before taking enforcement action. If we find that we must move quickly to address significant health concerns or egregious violations, we will consider immediate action – even before we have issued a formal warning letter.”

Adopting a global and integrated perspective of quality and regulatory compliance by multisite, international corporations will require no less an effort and no less keen minds and effective leadership than any other functional area of the corporation where the global strategies are deployed to manage growth and to identify, control and mitigate business risk. GMPs are part of a business risk strategy.

And for those who do not yet make a connection between GMP compliance and the business, consider this.

CNN reported this week (July 20, 2010) that Johnson & Johnson said the successive recalls, as well as the shutdown of the Fort Washington plan, resulted in a 27.5% sales drop and about $600 million reduction in annual sales.”

Presently all eyes are on Johnson & Johnson’s end of the lever.

The QA Pharm

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