Second Day of FDLI Enforcement and Litigation Conference Features Another Key FDA Enforcement Official

By Douglas B. Farquhar –

In the second day of the Enforcement and Litigation Conference sponsored by the Food and Drug Law Institute (“FDLI”), speakers from FDA and private industry discussed the trends in international trade in FDA-regulated products, and debated when companies  are required to disclose potential financial conflicts of interest.

David Elder, Director of FDA’s Office of Regional Operations, described how FDA has ramped up its efforts to inspect imported drugs, foods, and medical devices, and how FDA is increasing its overseas inspections of facilities regulated by FDA.  The PREDICT system (he was at pains to remember what the acronym stands for) has been inaugurated in one District of FDA, he said, and will be rolled out shortly to all 20 districts.  He said that the system, which addresses FDA-regulated products offered for import, enables inspectors to determine which import entries should be reviewed further by looking at the company and country of origin, type of product, and compliance history of recipient, among other criteria.  He said that he expects the system to enable FDA to automatically release for importation (rather than requiring that the product to be held, returned to the country of origin, or inspected) much more than the 20 percent of imported FDA-regulated products that are already automatically released.  He also said that he anticipates that FDA inspections overseas will increasingly be conducted in conjunction with regulatory authorities in those countries.

Katie McDermott, a partner at the law firm Morgan, Lewis & Bockius in Washington, D.C., referred to recent Corporate Integrity Agreements entered into by medical device or drug companies, and noted that the CIAs are beginning to require reporting to the government any in-kind contributions to physicians or their offices.  She noted that, for example, if representatives of a company provide training on the use of a drug or device to a physician or other medical personnel, the company may be required to report that type of activity.  Corporate Integrity Agreements, which are generally required when a mainstream drug or medical device company enters into a settlement with the federal government because of allegations of kickback or off-label promotion violations, have been executed and are in effect for dozens of companies.

Bradley Thompson, an attorney with Epstein, Becker & Green in Washington, D.C., argued that FDA needs to demonstrate increased transparency.  He noted that his firm has determined that FDA’s Center for Drug Evaluation and Research had promulgated 64 draft Guidances more than five years ago that have not been finalized or withdrawn.  He also stated that his clients are increasingly frustrated by filing comments on draft or proposed rules or guidances, and the comments are not addressed when the final rules or guidances are addressed.

In an additional update about the Conference, we should also report that Dan Miller of the Delaware Medicaid Fraud Control Unit ("MFCU"), yesterday reported that MFCU units around the country now have access to a centralized databank that can aggregate data from different Medicaid programs around the country, and match up diagnosis codes for Medicaid beneficiaries with drugs dispensed.  This enables investigators to determine, on a national basis, the amount of Medicaid reimbursements for a drug used by patients in off-label indications that may have been induced by a company’s off-label marketing.  The database can also be used to show increased prescriptions by specific physicians that government agents believe have received kickbacks.  Dan also mentioned, in response to a question, that some MFCU units around the country receive a percentage of the recoveries (much like a contingency fee for attorneys) when they successfully achieve a settlement with a targeted company, although his unit does not.

Further information about the conference, including audiotapes, will be available from FDLI.

Doug Farquhar co-chairs the FDLI Enforcement and Litigation Conference.