It’s Time for the White House to Focus on Drug Approvals . By Ryan Streeter
https://www.realclearpolitics.com/articles/2020/04/18/its_time_for_the_white_house_to_focus_on_drug_approvals_142941.html
In this COVID-19 era, it’s the scientists who will ultimately get us back to work. It is time for the Trump administration to acknowledge this and adjust its public communication strategy accordingly. It is hard to envision a scenario looking like the “normal” we all crave until we have therapeutics to protect us from the coronavirus’s effects as we await a vaccine to prevent us from catching it. Once we all know we can take a drug that will minimize symptoms and possibly prevent infection in the first place, we can interact safely in ways that even a ramped-up testing regime will not allow.
Daily White House briefings, and as a result the media and the American public, have been fixated up to now on the response to the pandemic from the administration and Congress. These updates primarily focus on three of the four main categories of activity: federal aid to businesses and displaced workers, needed supplies and equipment for our health care system, and the social distancing regimen complete with handwashing and homemade masks. The two medical faces of this crisis, Drs. Anthony Fauci and Deborah Birx, have concentrated on the last two and keep faithfully explaining what the administration is doing, or should be doing, to increase testing, equip frontline workers, and ultimately flatten the curve.
We hear much less about the fourth category of activity, that is, the race to find a therapeutic solution to combat the virus while we await a vaccine. Therapeutics include anti-viral drugs that inhibit the coronavirus and antibody therapies that boost immunity to the virus, and possibly off-label use of existing drugs.
As my American Enterprise Institute (AEI) colleague Scott Gottlieb has written, there are promising therapeutics that could be available this summer. This will not happen, however, without “a strong sense of urgency from manufacturers — and from regulators, who need to collaborate with drug developers in innovative ways” to speed things up.
To create a stronger sense of urgency, the White House should begin devoting more time in its daily briefings to the current status quo and timelines of drug approvals. In addition, the administration should increase its public messaging on the issue. This is important for three main reasons.
First, spotlighting our biomedical response regularly in front of the media and the public creates a kind of pressure that results in heightened accountability. Those responsible for getting more masks and ventilators to hospitals feel an appropriate level of pressure because that is where our focus has been. Federal regulators, especially at the Food and Drug Administration, should feel a similar level of pressure for drug approvals. Drs. Fauci and Birx should update the public regularly on what the FDA is doing to move along specific, promising treatments, and the administration should require the head of the FDA to explain to the media (as much as possible) where things stand.
Second, since the default mode of federal agencies is caution, which in turn translates into lost time, added pressure will also generate greater speed and attention to timelines. No pharmaceutical company or scientist wants to damage people’s lives by moving forward recklessly, but neither do they want the government to slow them down unnecessarily. The pressure of repeatedly being asked, “Has the trial timeline for this drug changed?” is very good pressure indeed. As Yuval Levin, another AEI colleague, has explained, the National Institutes of Health has the authority and capacity to coordinate scientists, labs, and timelines in a way that will achieve the speed we need. It just needs to be required to do so in a very public way, which only the administration can do.
Third, the more clearly the public understands the benefits and risks of certain therapeutics and the reasonable timelines for their release, the better businesses can plan for how to reopen fully, universities can plan more responsibly for the fall, and parents can send their kids back to school with greater confidence. We are in the midst of a big public debate about when and how to reopen the economy. Imagine how much better our planning will become when we can factor with greater confidence the introduction of certain therapeutics to the market.
Our scientists and biomedical professionals are the best in the world. Those who can help them do their work more quickly need to do so, and that always only happens when they feel the pressure to do so.
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