Addressing Viral Safety in Biologics with the FDA



Pharma IQ
11/18/2010

The importance of addressing viral safety in biologics has arguably never been greater, with high profile contaminations such as the Baxter and Genzyme cases in 2009 highlighting just how delicate the balance can be.

Add to this the porcine circovirus contamination of GlaxoSmithKline's Rotarix vaccine in March this year .

This appears to be the message being driven home by the US Food and Drug Administration (FDA), which has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics.

According to Dr. Rachel Behrman, associate director for medical policy in the FDA's Center for Drug Evaluation and Research this final rule "will expedite FDA's review of critical safety information and help the agency monitor the safety of investigational drugs and biologics".

She added: "These changes will better-protect people who are enrolled in clinical trials." The new rule will insist that certain safety information that previously had not been required to be reported to the FDA be reported within 15 days of researchers becoming aware of an occurrence.

This includes findings from clinical or epidemiological studies that suggest a significant risk to study participants.

In addition, the reports must include serious suspected adverse reactions that occur at a rate higher than expected, as well as serious adverse events from bioavailability studies which determine what percentage and at what rate the drug is absorbed by the bloodstream.

Bioequivalence studies which determine whether a generic drug has the same bioavailability as the brand name drug must also be reported.

The rule will additionally provide examples of evidence that would suggest that an investigational product may be the cause of a safety problem.

Under current regulations, drug sponsors often report all serious adverse events, even if there is little reason to believe the product caused the event, but it is felt that such reporting complicates and delays the FDA's ability to detect a safety signal.

"The examples address when a single event should be reported or when there is [a] need to wait for more than one occurrence," the regulatory body stated.

Additionally, the rule revises definitions and reporting standards so that they are more consistent with two international organisations - the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organisation's Council for International Organizations of Medical Sciences.

The FDA says that changes are designed to help ensure "harmonised reporting of globally conducted clinical trials".
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Developing successful strategies to avoid contamination, optimise clearance and ensure maximal viral safety is high on the agenda of the planet's multinational pharmaceutical organisations.

In the coming months, companies will be aiming to apply crucial aspects of international viral safety regulations to speed approval and time to market and ensure effective viral clearance using the latest techniques and studies to optimise procedures.

The FDA hopes that the final rules will ease this process and pave the way for greater safety in biologics, while enabling firms to optimise testing processes and guarantee viral and pathogen safety in stocks.

Along with this final rule, the FDA has also issued draft guidance for industry and investigators that provides information and advice about the new requirements and other information.

As viral safety remains in the biologics spotlight and the Baxter, Genzyme and Rotarix vaccines linger in the memory, it is clear that the FDA final rules are another step on the road to bolstering the safety of the sector as a whole in the months and years ahead.