Healthy Skepticism Library item: 18554

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
Feds Probe Payments In Overseas Drug Trials
Pharmalot 2010 Aug 9
http://www.pharmalot.com/2010/08/feds-probe-payments-in-overseas-drug-trials/

Full text:

As promised, the US Justice Department – along with the US Securities and Exchange Commission – is paying closer attention to interactions between the pharmaceutical industry and foreign governments (background). In recent months, at least five big drugmakers have received letters as the federal government seeks to uncover any violations of the Foreign Corrupt Practices Act, which forbids US companies from bribing foreign government officials.
Among those that have been contacted in recent months concerning their activities are AstraZeneca, Bristol-Myers Squibb, Baxter, Eli Lilly and Merck (see page 26 here). An AstraZeneca spokesman says the drugmaker is cooperating. A Lilly spokesman notes the drugmaker, which was the subject of a 2003 probe of its Polish subsidiaries, is also cooperating and has received additional subpoenas from the SEC.
Among the countries cited are Brazil, China, Germany, Greece, Italy, Poland, Russia and Saudi Arabia, according to Main Justice, which notes that the Arnold & Porter law firm recently issued a client advisory indicating the probe is also exploring whether drugmakers and clinical trial organizations pay off third-party investigators to finesse research data.
Why? A recent report by the HHS Office of Inspector General noted that eight percent of marketing applications to the FDA in 2008 relied exclusively on foreign data, 80 percent of approved marketing applications for drugs and biologics relied on at least one foreign clinical study, and 78 percent of all human subjects were enrolled at foreign sites.
“The number of third party contracts with CROs, academic and health care facilities, and investigators provides a high-risk area for potential violations. The US government is particularly interested in any corrupt payments that may have wrongfully influenced the reliability or integrity of data emerging from any trial, and companies may find themselves facing critical legal issues if approval of products rested on the results of studies that DOJ deems corrupt,” Arnold & Porter attorneys wrote, adding the “DOJ has recently taken the public position that many investigators, foreign clinicians, and laboratory workers will be deemed ‘foreign officials’ for purposes of the FCPA.”
Three years ago, device makers were similarly scrutinized. Among them was Johnson & Johnson, which voluntarily disclosed improper payments that were made by unspecified foreign subsidiaries in connection with the sale of medical devices in a pair of unnamed countries. An executive resigned as a result of the scandal (see here).