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.
Not surprisingly, this did not sit well with the FDA. “The complete omission of [side effect reports] required to be submitted … for a period of over four years raises concerns about your firm’s ability to monitor the safety of drug products.”
The FDA had another issue. Heritage lacks suitable procedures for gathering and evaluating side effect reports. And its policy of keeping these reports for no less than three years doesn’t jibe with FDA requirements, which state side effect reports must be kept for 10 years.
We reached out to Heritage for comment and will pass along any reply.
For the record, the FDA cited Galena BioPharma for the same problem last April. Before that, though, the most recent incident involved Sanofi in January 2011. Other companies cited in years past for the same infraction included Pfizer and GlaxoSmithKline.