Although Sen. Ted Cruz (R-Texas) is quarantined at home after coming into contact with someone who tested positive for Covid-19, the lawmaker plans to introduce a bill to permit the Food and Drug Administration to approve any drug, device, or vaccine that might be endorsed by regulators in certain other countries to combat the novel coronavirus.
The legislation, which is known as reciprocity and designed to meet a public health or unmet medical need, comes as researchers around the globe scramble to test new and existing medicines in the face of a worsening outbreak that has so far infected more than 125,000 people worldwide and been blamed for some 4,600 deaths, according to a World Health Organization update.
“Many countries with the renowned research facilities and safety standards are working to develop drugs and devices that will save lives and reduce the spread of this virus and when those cures are approved abroad, we need to be ready to bring them home,” Cruz said in a statement. “This legislation would do just, removing the regulatory barriers that often delay the approval new pharmaceuticals and medical devices for months. With the rapid spread of this virus, time is not a luxury we can afford.”
The reciprocity would apply to more than three dozen countries, including Australia, Canada, Israel, Japan, New Zealand, Switzerland, and South Africa as well the European Union or a country in the European Economic Area.
This is not the first time that Cruz has proposed such a mechanism to speed FDA drug approvals. Twice over the past five years, he introduced bills with nearly identical language, but in each case, he targeted life-saving medicines for which there were unmet medical needs more broadly. This latest bill, however, focuses specifically on the novel coronavirus.
In both instances, though, the bills went nowhere. That may have been due to concerns over approval standards in other countries, since the FDA is considered to be the gold standard among regulators. But given the extent of the pandemic and the difficulties the Trump administration has had coping with the coronavirus, the newest iteration may hold more appeal among lawmakers.
“The case would appear to be better for coronavirus. The risk-benefit ratio is different, because the potential social benefit is very large,” said Frank David, managing director of the Pharmagellan consulting firm, who analyzed an earlier version and found there would have likely have been limited impact, since there were few drugs for unmet needs for which alternatives did not already exist in the U.S.
“So in principle, it’s not unreasonable to think about reciprocal approvals in this situation. When we looked at the previous legislation, it mostly would have applied to drugs that were targeting small patient populations. This obviously could have a much, much bigger impact. But there are other issues to consider.”
Indeed, one legal expert, Erika Lietzan, an associate professor at the University of Missouri School of Law who specializes in FDA regulatory issues and administrative law, cautioned that the legislation requires careful review and should not proceed due to panic. It is worth noting that the bill would give Congress the right to override any product rejected by the FDA.
“In my view it is not a good idea to enact significant changes to FDA’s core provisions — such as the basic rules governing approval of medical products — in an emergency situation. There usually isn’t time to assess the language carefully, especially for unintended consequences. And there is a real potential for heightened emotions to skew judgment,” she wrote us.
She also questioned whether other regulators would be first to approve products, since the U.S. is such a big market for companies. “I think it unlikely that other major regulators will approve or clear coronavirus-directed medical products significantly before FDA does, and even if they do, the agency has sufficient flexibility to ensure patients who need access can get access before approval.”
David, by the way, made another point. The law would not extend to products approved in China, which has the pharmaceutical infrastructure and — in particular —motivation to quickly develop drugs and vaccines aimed at the coronavirus. China, however, is not on the list of countries covered by the legislation. “Given what’s going on, I’d be betting more new drugs being developed out of China than the EU,” he said. “And the law doesn’t address that.”