On 10 March, the White House announced that President Donald Trump will nominate Scott Gottlieb to lead the Food and Drug Administration (FDA) - a doctor and a pharmaceutical industry favourite.

It isn't really surprising that Trump picked Gottlieb, as they have many similar goals and aspirations for the drug regulatory agency. Firstly, Trump has been aggressive on pharmaceutical companies - since the beginning of his run for presidency until now - for "getting away with murder" with their "astronomical" prices of drugs.

Gottlieb has supported Trump by championing the idea of bringing cheaper generic drugs to the market. If Gottlieb is appointed, he would attempt to improve competition among cheaper generic products to bring drug costs down.

He mentioned in a speech during a conference in Orlando, Florida on 6 March that the rules for complex generic drugs that allowed brand-name companies to create "monopolies in perpetuity" should be overhauled. In addition, he called for competition to be implemented in situations whereby decades-old drugs are still provided by one generic supplier - by allowing other speculators to buy the drug formula and increase the price.

Faster drug approvals to boost innovation

Trump and Gottlieb also agree on faster drug approvals, albeit different ways of approach. Trump casually mentioned a 75% to 80% cut of the government regulations: "Instead of it being 9,000 pages, it'll be 100 pages," he said to a group of pharmaceutical company executives in January.

Gottlieb agreed by saying that the FDA's "hunger for extreme certainty about how drugs work" had become too burdensome. Perhaps being a Hodgkin Lymphoma cancer survivor he understood the plight of patients suffering from orphan diseases.

He cited the many hurdles for the FDA approval of a drug for Hunter's syndrome as an example - the FDA required the trial to involve 96 patients with Hunter syndrome and insisted that patients should be randomly assigned to receive either the experimental drug or an inert placebo.

Many also argue that because of the cumbersome FDA process, innovation has been halted as it was hard for new drugs to be brought to the market. But many independent researchers and public interest groups have criticised the argument stating that this would be a threat towards patient safety instead and the lack of new drugs is because discovering them is very difficult - not because of FDA's approval speed.

Letting doctors make decisions about drug safety

Gottlieb also wants to provide more power to doctors to make decisions about drugs. He said, "The modern FDA is driven by a profound lack of confidence in the ability of doctors to make careful judgements. The agency regulates drug makers, but it does not regulate doctors."

He claims that the agency has become too paternalistic when doctors instead should have more say about the safety of drugs available and whether they would be helpful to patients.

But what seems like a positive thing may actually harm patients in the process. Doctors usually do not have the time to make sure drugs are safe and effective; therefore FDA scientists are employed to do so. The 1960s thalidomide incident whereby an FDA medical officer Dr Frances Kelsey opposed the sale of thalidomide in the US proved the need for FDA scientists.

It would be extremely time-consuming for doctors to review clinical trials themselves and also compromise patient safety, especially when many results of clinical trials never get published.

Blood supplies and unsafe foods are more important

Many critics including Michael Carome, director of Public Citizen's Health Research Group are against Gottlieb's nomination.

“Scott Gottlieb consistently has advocated, among other things, further loosening FDA’s standards for approving medical products and lifting restrictions on the promotion of these products for unapproved uses,” said Carome. “His nomination would confirm Trump’s plans to move forward with a dangerous deregulatory agenda at the agency.”

Gottlieb has also said that if installed, his first acts in office would be focusing on the safety of blood supplies and the crackdown on unsafe foods, which he views as issues that deserve higher priority.

Not that the public has any say in this installment, but the Senate would have to review Gottlieb thoroughly to make a decision.

But at least, Americans can rest assured that Gottlieb supports the idea of vaccines. MIMS

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