July 29, 2016
July 29, 2016
On Friday, July 22nd, the European Medicines Agency (EMA) recommended the suspension of hundreds of drugs that had undergone bioequivalence testing at Semler Research Centre Private Ltd., a clinical research organization (CRO) located in Bangalore, India.
The World Health Organization (WHO) conducted inspections of two of Semler’s facilities in January and December of 2015, in which the WHO intended to “verify compliance with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) covering a number of studies.” During these inspections the WHO uncovered a number of critical and major GLP and GCP deviations, which were detailed in the inspections reports sent to Semler following each inspection. On April 12, 2016, the WHO issued a Notice of Concern (NOC) to Semler outlining the CRO’s violations, which include the “manipulation of at least five studies.”
During the fall of 2015, the FDA inspected Semler’s bioanalytical site, during which it found data irregularities related to bioequivalence studies. After the inspection, the CRO received a FDA Form 483, which outlined all of the observations found during the Agency’s visit. Semler submitted a written response to the FDA’s citations and conducted a retrospective investigative audit.
On April 19, 2016, the FDA issued an “Untitled Letter” to Semler stating that the CRO “did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of bioequivalence studies.” Furthermore, FDA’s letter noted that it has “significant concerns” regarding the validity and reliability of bioequivalence and bioavailability data generated by Semler that is submitted to the Agency in support of ANDAs or NDAs.
In addition, on April 20th, the FDA notified NDA and ANDA sponsors of the data integrity concerns stemming from studies conducted at Semler, and stated that clinical and bioanalytical studies conducted at the facility need to be repeated.
According to an article from FiercePharma, after receiving the FDA’s letter, Semler made a statement in which it claimed to have hired a “high quality consulting firm to review the data,” and stated that it planned to provide FDA with “a detailed response to these concerns with appropriate steps undertaken as advised by the agency.”
Due to the issues identified at the Semler Research Centre during inspections conducted by the WHO and FDA, the EMA announced that it is recommending the suspension of hundreds of drugs that rely exclusively on bioequivalence studies from the facility. EMA also stated that any products currently under evaluation, which rely solely on bioequivalence studies conducted at Semler, should not be approved until additional data is provided.
Most of the products that are impacted by these recommendations are generic medicines from companies such as Novartis, Teva, and Mylan, as well as a number of smaller Indian companies. However, according to a recent article from FiercePharma, “Novartis and several other drug makers were able to escape the holds on some products because they had additional data to support them.”
A full list of the products and companies impacted can be found in the EMA’s directive.
Quality and compliance issues are among some of the most serious violations that drug makers can be faced with. This is because of the serious safety risks these types of concerns pose to patients. As such, it is important to approach each project with consistency and accuracy in order to avoid issues involving the quality of your products.
Sometimes, despite your best efforts, you may still run into these or similar violations. In these circumstances, you need to respond quickly and appropriately to avoid further regulatory action. The Weinberg Group can help ensure that your products are of the highest quality standards, and if they aren’t, we can help you get there. We have significant experience in this area (and are not the “high quality firm” mentioned above) and we are uniquely qualified to help you with all of your quality and compliance needs.
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