If you have been watching Vice President Mike Pence and the medical experts responding to the coronavirus outbreak with measured reassurance, you might (like me) be wondering: Why the heck don’t we have more kits available to test for infection?
Roger D. Klein, a medical doctor and expert on regulation, argues that we have inflicted these kinds of delays on ourselves through overregulation. Writing in City Journal, Dr. Klein explains:
Laboratory tests typically contain what is termed a “negative control”—material expected to yield a negative result when tested, and which protects against false-positive results stemming from contamination or other issues. Many labs obtained positive results with the negative controls, invalidating test runs and precluding use of the kits. Affected labs were required to send their specimens to the overburdened CDC.
The FDA has not allowed the experienced and highly skilled professionals at public-health, academic, and commercial laboratories to set up their own laboratory developed tests (LDTs), and no manufactured test kits have been authorized for sale in the U.S. In Europe, several companies, at least one U.S.-based, have regulatory approval to sell test kits in Europe.
The FDA’s regulation of laboratory tests has been a longstanding concern. This includes moves to regulate LDTs, despite the existence of stringent alternative-regulatory and oversight mechanisms. In general, the FDA has exercised “enforcement discretion” with respect to LDTs. With coronavirus testing, the FDA’s abandonment of enforcement discretion may have proved deadly.
Complaints about the lack of testing access compelled the FDA to resolve what has become a self-inflicted crisis.
On February 29, the agency issued guidance expanding the number of laboratories eligible to provide testing and creating a pathway for them to use internally developed tests. The FDA, however, is forcing these labs—most of which have not been FDA-regulated—to expend scarce resources on the preparation and submission of EUAs. These submissions must be filed a mere 15 days after laboratories begin testing and must adhere to prescriptive validation requirements.
Pence has said that enough kits for a million tests will be available at the end of this week and that anyone can be tested for the virus with a doctor’s recommendation. The entire cost of the test will be covered by insurance, Medicare, or Medicaid.
But a million tests in a country of 331 million people?
More testing kits might have allayed the public’s concern and allowed the country to respond faster to the coronavirus.