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Howard Sklamberg, the former US FDA deputy commissioner for global regulatory operations and policy, was in Mumbai to address the India Pharmaceutical Forum 2018, an annual event where regulators, industry and other experts essentially discuss all things quality and compliance. (Also see "Data Integrity Failures Undermine Trust That Can’t Easily Be Won Back, EMA Official Says" - Pink Sheet, 28 Feb, 2017.)

In an interview with the Pink Sheet at the JW Marriott perched along the picturesque Juhu beach, Sklamberg, who is now with law firm Akin Gump as a partner in its health care and life sciences regulatory practice, outlined where things may be headed around the use of Park Doctrine powers by FDA. In December 2017, the agency indicated that it may consider clarifying the circumstances in which criminal charges can be pursued against an individual in a supervisory role under the Park Doctrine. (Also see "FDA Investigators Want Top Management Involved In Manufacturing Inspections" - Pink Sheet, 14 Dec, 2017.)

Sklamberg clarified that data integrity isn’t really an India-specific issue dispelling the general perception in some quarters. He also maintained  that the US-EU mutual recognition agreement on manufacturing inspectional findings doesn’t necessarily mean identical enforcement decisions by the partnering regulators. (Also see "US/EU Inspections MRA: Lessons Learned And Challenges Ahead for FDA" - Pink Sheet, 23 Feb, 2018.)

Sklamberg, considered during his tenure at the FDA as a top go-to official at the agency on domestic and international quality and safety regulations, served previous stints included roles as prosecutor in the US Attorney’s Office in Washington and in the Public Integrity Section of the Criminal Division at the Department of Justice. (Also see "Top US FDA Global Regulator Joins Major Law Firm's Health-Care Division" - Medtech Insight, 11 Jul, 2017.)

US FDA approvals of generics has been galloping, providing impressive data to back efforts by Commissioner Gottlieb to position the agency as part of the solution to the debate around high drug prices. What’s your general take on fast versus need for more rigor in preparing and assessing submissions?

I have not seen any change in the FDA’s rigor in evaluating applications or in inspections or in oversight. I think FDA is paying at least as much attention to detail as it had in the past. The FDA can achieve an increased pace by increasing staffing and also by some internal efficiencies caused by its reorganizations and by the development of lot of policy. When you develop policy you don’t have to rethink the same issue. I also think  in the future, the mutual recognition agreement with Europe is going to free up resources that had been used in European inspections and redeployed.
How do you see things playing out around the FDA’s  “responsible corporate official” or Park Doctrine powers to hold top officials responsible for manufacturing issues and problems?

It’s an area that one day the courts may weigh in on. There was a case a couple of years ago involving a recall of eggs where some corporate executives were sentenced to prison for Park Doctrine misdemeanors. It went to the court of appeals, which affirmed the conviction but it was a very divided court. And that court, which is one level below the Supreme Court, stressed that there are limits on the Park Doctrine.   I think that the defense bar will litigate on what the limits are of the Park Doctrine in appropriate cases and I think the justice department in FDA will pick and choose the cases in which to apply the Park Doctrine, because if they push the Park Doctrine too far, my guess is that the courts wouldn’t allow it.   I think it’s a tool that the FDA and the Justice Department consider very important and it’s one that they will continue to use in appropriate circumstances but I also think that courts will increasingly find that there are limits on how far it can be pushed. 
The FDA has been keen to deal with REMS [Risk Evaluation and Mitigation Strategy] abuses that block generic entry; do you anticipate momentum in coordinated action with the FTC?

Historically, the FDA and FTC have had a strong co-operative relationship. They work together in areas like health fraud, which is selling of bogus therapies to victimize consumers. So they already have that relationship. I believe that the [FDA] Commissioner thinks it’s important and I do think that the agency will refer cases to FTC which will then investigate.
Mutual recognition agreements (MRA) like the EU and US formed last year to recognize the findings of inspectorates in each other’s jurisdiction could free up resources. But could it also be a double-edged sword for industry, raising the need to get compliance right the first time?

I would say that some firms are going to be inspected less often - firms that have lower risk profiles. And it is less likely that a firm in the US or Europe is going to see a duplicate inspection. What’s important about the agreement is that it preserves the right of the EU and the US to make different enforcement decisions based on even the same set of facts.  I think there will always be differences between approaches in the EU and the US to particular situations because the systems are slightly different. 
There is this overarching impression by some that data integrity is more of an India-specific problem – myth or reality and are things improving?

I think it would be a mistake to think that data integrity is an Indian problem as opposed to an issue that should concern drug manufacturers around the world.   The FDA has taken enforcement action on data integrity throughout the world and I think it will continue to do so. Statistics are difficult because there isn’t really a standard definition of data integrity. At the extreme end of the spectrum, everyone would recognize a data integrity issue – deliberately falsifying data. But there are more minor forms  - minor GMP issues – that some people may consider data integrity issues.  But, I do not think data integrity is unique to India. 
So, is there a need to have a more specific definition of data integrity, since it can bring down companies?

It’s difficult. ... There’s a broad definition. Like a lot of things, a firm can have an isolated incidence of a breach of the GMP regulation related to the storage of data. When it’s minor like that a lot of people look at it and say that’s a GMP issue and the firm should address it but it’s not data integrity in the sense of widespread falsification of data in a willful manner.
What are the three core issues that you believe that Indian firms should focus on in terms of compliance, going by the overall trends you’ve seen over the past?

Learning from mistakes, continuously improving quality systems and data integrity. The first question a regulator will ask when going back to a firm that had an issue before is why is this happening again? What did you learn from the previous time and what steps did you take? I think drug manufacturing is an enterprise that demands continuous improvement and that’s something that the FDA and other regulators concentrate on. FDA, in particular, likes to focus on corporate-wide issues. What it looks for is if a firm has a problem in one facility, is it going to redress just the issue in that facility or more systemically improve its operations.


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