Outgoing head of GlaxoSmithKline Jean-Pierre Garnier does not foresee the US Food and Drug Administration softening its stance on medicine approvals, he has told the Financial Times in an interview before he steps down at the company’s annual meeting next week. “This is not a pendulum,” he says, “society wants to avoid risk. We have to tease out rare side effects earlier.”
The agency has raised the bar and companies will have to adapt, he warns, shifting their drug development focus to trialling compounds in targeted sub-populations of patients to better spotlight any rare side effects ahead of regulatory submission. Whereas other senior industry personnel have suggested the US election has strongly impacted the FDA’s position on new drugs, Garnier believes “the market will get reconstituted” with a new focus on so-called “progressive blockbusters”, which will in turn cut drug development costs by weeding out false negative results sooner.
But with the Pharmaceutical Price Regulation Scheme re-negotiations still ongoing in the UK, where GSK is based, and warnings of a shift away from the country for pharma R&D, Garnier told the Financial Times: “We want to compete on the basis of innovation. The translation of policies has to take account of those needs. As long as they do, we’ll be very happy to continue to stay….but you cannot handicap us.”
It is understood Garnier will assume another healthcare role after he steps down as chief executive next week. He earlier confessed to the Financial Times that there are things he wishes he had done differently, including earlier dissemination of the data for its beleaguered diabetes drug Avandia (rosiglitazone), but that overall he has “no regrets”.
