Industry in Panic Over Fallout of FDA Note on Indian Firm’s Data Integrity
Some large Indian drug cos may feel impact of call to repeat some studies, say sector insiders
Vikas Dandekar & Prabha Raghavan
Mumbai|New Delhi: A note from the US Food and Drug Administration (FDA) informing drug companies last week about data integrity concerns at Semler Research has sent panic signals across the Indian pharmaceutical industry. The US agency had called drug firms to repeat certain studies earlier done by Semler, adding that the studies submitted from the contract research organisation (CRO) outfit will not be acceptable.
In its note, the FDA said it is taking the action based on its inspections between September 29 and October 9 last year, but did not specify a time frame for which the studies will have to be repeated. The drug companies that may be impacted bythe latest action could not be identified immediately but top sources in the CRO industry said a few large Indian drug makers may feel the impact. Generally, drug firms outsource several projects (bioavailability/bioequivalence studies) at any given time to several CROs, based on their track record of quality and delivery within set deadlines. While most companies farm out work to external agencies, some do piecemeal work using internal resources.
“For each new filing or generating new data, a company needs at least 8 to 9 months and it costs up to $1,00,000,” said an independent consultant, asking not to be identified. He mentioned that in some term sheets signed with the CROs, companies have started to include indemnification clauses in the legal contracts that cover loss of market share and additional costs for repeating studies.
The FDA inspections had found significant instances of misconduct and violations of federal regulations, including substitution and manipulation of study subject samples.
In its response to ET, a US FDA spokesperson declined to share information regarding the affected companies. It noted, “Federal law prevents us from disclosing information related to contracts between sponsors and third parties such as cont- ract research organizations (CROs), and identifying the affected drug products would reveal that information….Federal law also prevents us from commenting on pending applications.”
The FDA said Semler conducts bioequivalence and bioavailability studies for a number of pharmaceutical companies. While the latest action by the US regulator did not specify a need to withdraw the existing products from the market, the directive to repeat the studies could mean a temporary disruption in supply of the products besides an unexpected financial stress for the drug companies that will have to repeat the studies for resubmissions. The inspection found significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples.