It will come as no surprise that the new chief of the FDA faces a raft of issues as he takes on his new role.
The opioid crisis
This is the one we keep hearing about. Gottlieb is keen to address opioid drug use in the US but it won’t be easy. He is due to meet up with health and human services secretary Tom Price next week who has been on an opioid abuse listening tour.
Earlier this month the FDA announced plans to improve healthcare provider training and education around the prescription of opioids. It also presented a workshop inviting stakeholder opinion on how to improve education around prescribing opioids.
Getting drugs to market faster
Despite the FDA approving drugs faster than any other global agency, there have been calls new drugs to hit the market faster - something Gottlieb is apparently keen to address. Of course issues of safety will need to be at the forefront of this initiative.
Earlier this year Trump made it clear that he found the approval process too slow. The flip side of this is that a recent Yale School of Medicine study found that around one in three drugs approved by the FDA have been found to have safety issues which have been discovered in the three years after approval. According to Yale News, ‘while most of the safety concerns are not serious enough to require withdrawal of a drug from the market, the finding highlights the need for ongoing surveillance of new drugs in the post-market period, said the researchers’.
Generic drug labelling
Last year Gottlieg told the Regulatory Affairs Professional Society (RAPS) Regulatory Focus: “FDA needs to bear more responsibility for updating the labels of old generic drugs and can take on that role, rather than foisting it onto generic drug makers in a way that will not only increase generic costs and expose them to the same sort of failure to warn suits that plague branded companies, but will undermine the generic model by creating incongruities between the labelling of the same generic drug, solely by virtue of the manufacturer and what CBE [changes-being-effected] supplements they happened to file. I think this is the most inefficient way to achieve what FDA purports to be their public health goal here, which is why I believe this was politically contrived, or at least politically influenced.”
21st Century Cures Act
Recently passed, this act aims to speed up how new drugs can gain FDA approval faster. When the bill was first discussed last year, the Wall Street Journal (WSJ) desciribed it as the: “passage of legislation aimed at speeding up Food and Drug Administration approvals, combined with an incoming president who has pledged to ‘cut red tape’ at the agency, is expected to usher in a new, more industry-friendly era of drug and device regulation.”
The bill received the support of the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Advanced Medical Technology Association (AdvaMed).
It is thought that Gottlieb will move quickly to cement FDA mandates in the act. Speeding up the drug approval process by changing clinical trial regulations and make better use of real world evidence is part of the act.