Pharmaceuticals Shunning Push by Trump for FDA Shift

President Donald Trump has vowed to roll back regulations imposed by the government by 75% or more and that has caused great anxiety amongst some executives with pharmaceutical companies.

The worry is a less strict Food and Drug Administration would make it more difficult to gain insurance coverage for their latest expensive medicines.

The possibility of change at the federal regulatory agency has come as drug makers are being criticized for their high prices.

That includes Marathon Pharmaceuticals that announced on Monday it would delay it launch of a treatment for Duchenne muscular dystrophy after lawmakers in the U.S. questioned its yearly price of $89,000.

An industry trade organization said that during discussion with high level advisors of President Trump, lobbyists urged the White House not to name a new FDA commissioner who would act in a way to speed up the approval process at the agency for new medicines.

That same sentiment was also echoed by a number of biotech and pharmaceutical executives who said the FDA has already adopted new development models for new drugs and warned that looser review would cause risk to patients.

One pharmaceutical R&D leader said that often times people argue the FDA can be too restrictive, but we believe there is a good balance, as you need to have a risk/benefit profile that is well-characterized.

That type of stance underscores today’s unique position that members of the drug industry are in, when it relates to regulating products.

While the majority of sectors welcome a reduction of oversight, drug makers said a strict review process is very critical to convincing insurers and physicians that there is value in new, pricey medicine.

Otherwise, the money involved and time it take to bring to market a new medication can cost as much as $2.6 billion, which would be lost if insurers did not want to pay for the new product.

One CEO of a leading pharmaceutical said that it was important the new White House administration was seeking more deregulation so the private sector remained competitive, but there needs to be evidence of value in the industry.

He added that the FDA needs to speed the approval process of generic versions that are lower cost for drugs that have lost protection from patents.

Health insurers have pushed back against the increase in drug prices. Sales of new, expensive cholesterol drugs from Regeneron and Amgen have become stalled as health insurers limit their coverage until results are seen in trials that are able to prove the drugs lower risk significantly for heart attack as well as other cardiovascular crises.



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