Trump Takes Aim At Regulations Hindering Covid Recovery - American Commitment

By Jon Decker

Last week, President Trumpissued an executive orderdirecting federal agencies to halt or repeal regulations that impede America’s recovery from the coronavirus. Trump’s focus on tackling government red tape for the next phase of the Covid recovery should be applauded — if there is one thing the pandemic has made clear, it’s that we need more social distancing between bureaucrats and the federal register.

From the onset of the virus, bureaucratic incompetence has hindered America’s recovery. First, the CDC mass-produced coronavirus tests that were contaminated with live virus. If that wasn’t enough, a federal regulation pre-dating the Trump administration made it more difficult for the private sector to step up and cover the CDC’s testing gap.

As the Competitive Enterprise Institutenotedin a detailed report:

Under the Food, Drug and Cosmetic Act, diagnostic tests are considered medical devices and therefore subject tothe FDA’s premarket review requirements. Under normal circumstances, the FDA has used its enforcement discretion to waive the premarket review requirement for tests developed and used exclusively within a single laboratory, known as “laboratory developed tests”(LDTs).

However, when the Secretary of Health and Human Services declares an official public health emergency, the agency does require premarket approval for LDTs, though it will grant an expedited Emergency Use Authorization for LDTs that meet the necessary criteria.

Translation: The CDC sent out tests contaminated withlive virus, and the FDA said the private sector must have its approval before selling alternatives. No wonder Reagan said the scariest words in the english language were “I’m from the government, and I’m here to help.” Repealing the FDA’s burdensome testing regulations is critical to ensuring America is better prepared for the next pandemic.

Another area overdue for regulatory reform is streamlining the approval process for new medicines. The Competitive Enterprise Institute explains:

Under theFood, Drug and Cosmetic Act, the FDAhas implemented a three-phase testing regime that subjects new medicines to a progressively more stringent and time-consuming set of clinical trials.

Phase I trials test these products for acute safety in a relatively small number of healthy subjects. Phase II trials involve slightly more subjects, who are actual patients, and begin to
analyze safety at therapeutic doses and provide early indications of effectiveness. Phase III trials involve large numbers of patients, and testing examines bothsafety and efficacy. Phase III trials are considered the gold standard ofclinical testing, but they are time-consuming and expensive, which significantly delays the introduction ofmedicines for patients who need them.

Conditional approval following a single Phase II trial can provide access to promising medicines for patients who are willing to try medicines still in development in consultation with their doctors.

If a person is afflicted with a novel virus, and their health outcome is uncertain — shouldn’t they have the option to try any cure that shows signs of promise? President Trump made progress in tackling this problem by signing his Right to Try law, but there is still more work to be done to give patients greater access to new cures.

While the spread of the coronavirus may be slowing in the United States, the underlying bureaucratic problems still persist. If they aren’t reformed, they will kneecap our response to the next pandemic — potentially a more serious one.