FDA roadmap highlights opioids, gene therapy, biosimilars
- The Food and Drug Administration's 2018 strategic policy roadmap highlights the battle against opioid addiction, the growth of cell and gene therapy, and using competition to improve access and make drugs more affordable.
- Identifying where pharma is "inappropriately impeding generic competition" is also on the agenda, including guidance on REMS.
- Final guidance on communication from developers to payers about economic consequences of products is expected, in a bid to promote value-based contracting.
In December 2017, the Food and Drug Administration revealed its 2018 goals. This week's roadmap spells out the details, reflecting Commissioner Scott Gottlieb's priorities, including promoting more generics and biosimilars to tame high drug prices.
"Our roadmap is not intended to be … an exhaustive list of the important policies that FDA will initiate and pursue over the coming year. In focusing on these selected efforts, we will optimize our resources to achieve clear deliverables that will yield results over the next two years," Gottlieb said in releasing the 18-page blueprint.
First on the shortlist is the ongoing fight to contain the opioid addiction crisis, which shows no sign of abating. Deaths from overdoses are still climbing, a trend linked both with increasing numbers of prescription opioids being sold to pharmacies, hospitals and doctors' offices, as well as inappropriate prescribing for long periods.
The FDA's answer includes ensuring that prescriptions are for the right patients at the right dose and duration, and that patients with addiction issues get access to the correct treatment. Science also plays a role, through safer formulations, less addictive pain therapeutics and better treatments for addiction.
The agency also pledged to advance frameworks to expedite the development of safe and effective gene therapies and cell-based regenerative medicine products. In relation, an expansion of FDA oversight and enforcement of false health claims about cell-based regenerative medicine products is on the agenda.
What's more, the FDA highlighted how gaining access to treatment can be a challenge, especially amid higher prices for the new wave of biologics, and cell and gene therapies.
Promoting "vigorous" competition through the launch of generics and biosimilars can act to drive down prices and stimulate new approaches, according to the FDA.
"Lower prices late in the life of medical products do not hinder innovation because they occur so much later than the decisions to invest in the [necessary] research and development," the roadmap states. "Thus, innovation — itself driven by competition — improves health care and promotes access by providing products that would otherwise be unavailable, while competition for older and once innovative products promotes access by lowering prices."
Actions to this end include identifying areas where branded firms are inappropriately impeding generic competition, and issuing final guidance on "product developers" communication of information to payers about the economic consequences of their products which may promote value-based contracting."
- FDA Statement
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