Regulatory Focus™ > News Articles > Facing Major Repercussions from Bad Inspection, Impax Doubles Down on Compliance

Facing Major Repercussions from Bad Inspection, Impax Doubles Down on Compliance

Posted 21 May 2013 | By Alexander Gaffney, RAC

Pharmaceutical manufacturer Impax Laboratories has announced the formation of a new Compliance Committee it says will be focused on providing oversight for the company's regulated activities after the US Food and Drug Administration (FDA) identified major deficiencies at one of the company's manufacturing facilities.

Background: Generic Issues

Impax is coming off something of a tumultuous period.

On 15 March 2013, FDA announced it would withdraw approval for the company's generic equivalent of bupropion, Budeprion XL 300 mg, after the agency's testing confirmed that the drug was not sufficiently bioequivalent to its reference listed drug, Welbutrin XL 300 mg.

Curious in that withdrawal, however, was what wasn't withdrawn: products manufactured by Impax's competitors. Four other manufacturers-Actavis, Watson, Anchen and Mylan-all manufactured other variations of the same generic drug. Because the other products were approved in manner similar to Impax's, some industry analysts speculated that the other generic products could soon find themselves withdrawn from the market as well. But while FDA has ordered those manufacturers to conduct studies of their bioequivalence using updated standards, it said in a statement that it "believes that the bioequivalence issues with the Impax/Teva 300 mg product may have been the result of that product's particular formulation and thus limited to that product."

"Based on the information available to us, we do not believe it is necessary to withdraw approval of these products prior to completing our review of the results of the confirmatory BE studies," FDA added. "Once our review of the study data is complete, FDA will take any appropriate regulatory action."

A Disastrous Inspection

Impax's issues have gone much farther than bupropion, however. On 4 March 2013, it announced that the US Food and Drug Administration (FDA) had, after conducting an inspection at its California facility, determined that the facility had 12 deficiencies, and issued it a Form 483. Those deficiencies sent the firm's shares plunging, leading at least one law firm to solicit stockholders for a lawsuit against the company for allegedly ignoring warnings and failing to get its products to market as quickly as possible.

At least three of the observations made against the company had been identified in prior reports, and the problems were enough for FDA to reject the company's application for its prospective Parkinson's drug Rytary, which Reuters noted was due to be launched in early 2014.

Now, in light of the impact of the latter of these two issues, Impax has announced that it's beefing up its compliance approach to start addressing some of the problems now threatening its drug development pipeline's progress.

In a statement released on 20 May 2013, the company said that the three-person committee will  "provide oversight for all activities of the Company related to the U.S. Food and Drug Administration (FDA) warning letter for the Hayward site including obtaining approval of the Company's New Drug Application for an investigational drug, Rytary"

"The Committee will also provide oversight for the Company's Quality Improvement Program (QIP) with respect to change management, training, documentation, investigation, validation and risk assessments in response to the FDA 483s," Impax added.

Those three are not of light credentials, Impax takes pain to note. Between the three are a member of the Institute of Medicine, a co-founder of Watson Pharmaceuticals, and a former senior vice president of Teva Pharmaceuticals.

But while stockholders might be impressed, the real question remains unanswered: Will FDA?

Impax: Impax Board of Directors Establishes Compliance Committee


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Tags: Impax, 483

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