In addition to those qualities listed in Thursday’s post about the FDA Commissioner that Obama must choose, there is also a great deal of unfinished business – principally three things, that the next commissioner must turn attention to pronto. Today’s news carries articles stating that President-elect Obama is ordering a review of the vast array of whacky Bush executive orders to decide which ones need to be repealed right away (stem cells, e.g.). Similarly, it is important that the next FDA commissioner look to the agency’s unfinished business and, even before enunciating a strategic plan and executing some strategic communications, set about to set things right.
- FDAAA Implementation – First, develop a road map for the full implementation of FDAAA. Seek congressional input. Tell us what the map is and set to it. The pipeline is getting clogged with Complete Response Letters and PDUFA dates that are changed, which is in the interest of no one. The longer a drug waits to get approval, the less time it has on the market with a patent and the more expensive it will have to be. Too many drugs are languishing, not on the shelves at a cost not only to companies, but to patients.
- REMS and RiskMAPs – Second, clarify some FDA policies. Notably, FDAAA sets up the framework for Risk Evaluation Management Strategies, which are supposed to be an improvement over existing Risk Management Plans (RiskMAPs), but the agency has done a poor and ineffective job of communicating what exactly companies should consider in the development and packaging of REMS programs. Instead, the FAQ provided by the agency lists risk management tools that have long been part of RiskMAPs without talking about effective evaluation and modification strategies, which is supposed to be the improvement offered by REMS. The FDA’s efforts with respect to REMS have been inadequate. The list of approved REMS strategies include things like Medication Guides, a tool long in use, questionable in effectiveness and something that was always part of a RiskMAP. A Medication Guide does not address the key difference in REMS – the evaluation and management components. The agency has not provided adequate guidance on this front, leaving companies to guess what would be adequate, and causing the issuance of Complete Response Letters because of it.
- Provide Guidance on Digital Media – Third, enunciate some points of view about the uses of digital and social media by pharma in marketing. The potential for use of YouTube for example, is extraordinary, from PSA’s to patient education videos, to risk management tools whereby the metrics of YouTube now offer evaluation components. But since the regulatory cultures of most pharmaceuticals is generally conservative, most are waiting for FDA to say something. The truth is, while social media has all started out as a tool for people to talk to each other, business has been quick to follow. Private companies and even government are now on Twitter. It is time for FDA to be a leader, not continue to be a follower, and give companies some guidance – and further, that guidance should be – it is the medium, not the message. Digital media is no different than print or broadcast. It is not the medium in which you say it, it is what you say. Just that would be a tremendous help.
There is of course more, but those represent a few of my priorities as I see them.