Pharmaguy's Insights Into Drug Industry News

Blame it on the contractor.

That’s the reason Heritage Pharmaceuticals gave the Food and Drug Administration after an agency inspector found 10 instances in which the generic drug maker failed to convey side effect reports about its medicines, which is required by law.

Between 2010 and 2014, the company did not submit an unspecified number of side effect reports concerning an undisclosed number of its drugs, according to a Nov. 5 warning letter that the agency sent to the drug maker.

Such violations are rare.

Whenever a drug maker receives a side effect report about one of its medicines, the information is supposed to be conveyed periodically to the FDA. This is standard procedure, but one that is taken seriously by regulators, since they must detect troubling trends with drugs.

By and large, drug makers are keen to comply with this requirement. Not only do companies fear the wrath of FDA officials, they want to avoid the suggestion they are unwilling to disclose side effects. In fact, only once during the past four years has a company not filed required reports, according to the FDA database. And there have only been eight other instances during the past decade.

But in its annual reports filed with the agency between 2010 and 2014, Heritage noted that there were no side effect reports. Yet, an agency inspector found at least 10 such instances. So what was the problem? When confronted with the discrepancy, Heritage blamed a regulatory affairs contractor for the failure, according to the warning letter.