Is Your Compliance a Throw of the Dice?

As a stronger FDA steps up its enforcement efforts, process control and data management still elude some manufacturers. Compliance consultant Michael Gregor analyzes trends

By Agnes Shanley, Editor in Chief

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President Obama’s first 100 days in office have already signaled a major change in the Administration’s stance toward FDA. Sympathetic observers say the Agency has struggled with unfunded mandates, rapid industry globalization and staff morale issues ever since former president Ronald Reagan trimmed the ranks of its reviewers and inspectors in the 1980s.

Although the nominee for FDA Commissioner, Margaret Hamburg, has yet to be approved, her deputy, Joshua Sharfstein, whose tenure has already begun, has long been critical of industry practices.  

Sharfstein also spent time working as an aide to Rep. Henry Waxman, who has long accused FDA of “getting too cozy” with industry, and who analyzed and attacked its enforcement record last year (you’ll find the report here).

The heparin recall intensified criticism of FDA, particularly from Senator Chuck Grassley and Rep. John Dingell, and studies on global inspection showed that the Agency was unable to keep up with inspections of foreign facilities.

Setting the new tone, even before the new President was elected, were key bills strengthening FDA’s enforcement powers, as well as the appointment of consumer advocate Sydney Wolfe to FDA’s Drug Safety and Risk Management. Now, observers note that the Agency seems more determined than ever to distance itself from the industry, and to step up enforcement.

Speaking even more eloquently to the change in climate is the $3.2-billion budget that FDA has requested for 2010, representing a 19% increase from last year. This figure includes budget increases of $295.2 million and an extra $215.4 million in industry user fees.

 Drug companies that do not have a compliance strategy in place may soon pay a very high price, said Deborah Autor, Director of Compliance at FDA’s Center for Drug Evaluation and Research (CDER) at the FDLI conference in Washington, D.C. last month. The Agency’s top priorities this year, Autor said, will be:

• Swift, aggressive enforcement action
• Civil monetary penalties
• Increased scrutiny of data integrity, global operations and unapproved drugs

Clearly, FDA enforcement actions are on the rise (Figure 1), and the number of FDA warning letters and clinical Notice of Initiation of Disqualification and Opportunity to Explain (NIDPOE) are trending up (Figure 2). By mid-April, only four months into this year, they were already at nearly half the level of last year. 

In the meantime, enforcement timelines are becoming “head spinningly” short. For instance, only a few weeks separated the last FDA inspection of KV Pharmaceutical’s manufacturing facilities and the issuance of a consent decree. This was the second consent decree that FDA issued within a two month period this year.

As the importance of offshore drug manufacturing centers increases (Figures 3 and 4), inspection of foreign manufacturing plants has increased dramatically this year, after the establishment of FDA satellite offices in China and India. Table 1 summarizes key enforcement activity this year, and companies in the U.S., Canada, China and India all figure into the picture.

Data integrity was seen in the Warning Letter sent last month to a Chinese heparin “manufacturer” that was actually a “shadow plant” handling materials made elsewhere. 

FDA also cited its Application Integrity Policy against Ranbaxy’s Paonta Sahib plant in India, when the truthfulness of information in its drug applications came into question.

Clinical practices are undergoing much greater scrutiny, too, ever since a sting operation within the Office of Management and the Budget revealed shady practices in establishing Institutional Review Boards (IRB’s). Three weeks after a congressional hearing showed that one contract IRB had approved a fabricated study involving a fake device, FDA issued a warning letter to the company, Coast, which went out of business a few months later.

We asked consultant Michael Gregor, CEO of Compliance Gurus (Boston, Mass.) to update his last assessment and critique the industry’s FDA compliance for 2008 and 2009. Two years ago, Gregor, whose library houses extensive data on enforcement actions and regulations, cited data management, training, validation (particularly for software and IT systems), SOP writing, and process control as key problems. 

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