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In Notable Shift, DOJ to Treat Manufacturing Regulations as 'Top Area of Focus' in 2013

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By Alexander Gaffney, RF News Editor

In a notable shift, the US Department of Justice (DOJ) is has announced that current good manufacturing practices (CGMPs) will be one of the agency's "top areas of focus" in the coming year, opening up new areas of uncertainty for those involved in compliance and regulatory activities for the pharmaceutical industry.

In remarks made at the Pharmaceutical Compliance Congress (PCC) on 29 January 2012, Maame Ewusi-Mensah Frimpong, deputy assistant attorney general for DOJ's Consumer Protection Branch, noted her division has long worked closely with the US Food and Drug Administration (FDA) to promote the safety of pharmaceutical products.

Frimpong's department has been one of the driving forces behind some of the largest settlements in the pharmaceutical industry's history, including several in 2012 involving GlaxoSmithKline, Abbott Laboratories and Merck. But all three of those settlements focused on one thing: misbranding.

"In the area of misbranding, when companies make promotional claims that are not truthful and balanced, or when they do not disclose all relevant safety information to FDA and doctors, they place patients at great risk of harm because neither doctors nor patients can make informed choices about their drugs," Frimpong said.

All three companies were found to have misbranded several drugs over several years in the 2000s, and were collectively forced to pay billions in fines to the US government, with other civil and state lawsuits still pending for similar reasons.

A Big Shift to CGMPs

But a focus on CGMPs would mark a dramatic change in practice for the agency, remarked Scott Liebman, a principal at Porzio Bromberg & Newman and vice president of Porzio Life Sciences, a consulting group focused on pharmaceutical compliance issues, in an interview with Regulatory Focus.

"This is out of their normal zone of activity," Liebman said. "This very direct focus on CGMPs is a shock."

Liebman explained that Frimpong's remarks raised a huge number of unanswered questions among those in attendance, including whether the agency has the capacity to take on additional areas of focus while maintaining current levels of attention on misbranding issues, which areas will represent the 'low-hanging fruit' for initial agency actions, and where the majority of the agency's focus might eventually come to rest.

A number of high-profile pharmaceutical compliance issues came to light in 2012, including a rash of drug shortages caused by CGMP issues in a number of facilities, including ones overseen by Genzyme and Ben Venue Laboratories, as well as pharmaceutical compounding problems seen at facilities large (Hospira) and small (New England Compounding Center). Many of those drugs were sterile injectable drug products, though Frimpong's remarks did not specify if those types of drugs would be of particular interest.

Liebman said neither he nor any of the other PCC attendees he spoke with had any indication regarding which event, if any, precipitated DOJ's decision to place more of an emphasis on CGMPs.

Advice for Industry

"There's going to be a learning curve," Liebman said, adding that even if an investigation starts off looking at CGMPs, "Who knows where it will end up."

Frimpong suggested that companies ask themselves five questions:

  1. Do we have the right people in place with the right training and expertise?
  2. Are the right incentives in place to catch, report and fix problems?
  3. Are regulatory and compliance people engaged such that they are less likely to leave the company, leaving a vacuum of oversight?
  4. Are our regulatory and compliance policies realistic and working harmoniously?
  5. Are the right oversight procedures in place to make sure policies are working as intended?

The key takeaway, Frimpong said, is to focus on the human element of the equation. "People are not fungible, especially when it comes to the complex and highly technical issues that arise in a pharmaceutical production line," she added.

Companies would do well to do a better job at breaking down regulatory and compliance silos to make sure people are more broadly educated about both CGMP and Prescription Drug Marketing Act (PMDA) requirements to be able to handle DOJ's increased scope of interest, said Liebman, particularly in light of Frimpong's advice to break down barriers between segments.

Challenges Ahead?

But even as industry analysts question why DOJ has made this switch, they are also questioning what its effects might be. Companies have in the past been seen as willing to settle with DOJ over misbranding complaints, paying huge sums of money and agreeing to marketing-based corporate integrity agreements (CIAs) that are meant to improve internal compliance to prevent future deficiencies. But those activities largely front-load expenses—the fines, which can range from millions of dollars to more than $3 billion—while CGMP legal actions might distribute them differently.

In the case of Johnson & Johnson manufacturing subsidiary Ben Venue Laboratories, CGMP deficiencies caused its Bedford, Ohio plant to be shut down while the company spent nearly $300 million to upgrade the facility in addition to the cost of recalled products. It eventually signed a consent agreement with FDA to resume limited operations, but is still not up to its full manufacturing capacity, even years after its initial shutdown.

Liebman said this scenario illustrates that "the consequences are going to be different" for companies found to have severely violated CGMP regulations relative to those have severely violated branding or advertising regulations. "They could be more painful," he added.




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