A Surprise Group Pushes Back Against FDA Deregulation

Trump has spoken out a lot recently about rolling back regulations at the Food and Drug Administration up to seventy-five percent. According to him, this would bring down the cost of prescriptions, as well as allow needed medications to reach patients faster. Several groups, including the FDA itself, have pushed back, warning the President* of the potential dangers; the FDA has also reminded everyone it was streamlined several years back and does not believe any additional deregulation is possible.

Executives at more than a dozen pharmaceutical firms told Reuters they are concerned that fewer regulations would compromise patient safety as well as prevent insurance companies from allowing the medications to be covered and purchased by consumers. If that were to happen, it would do them no good at all to make any changes.

“People often argue that the FDA is too restrictive,” said Roger Perlmutter, head of research and development at Merck & Co Inc. “We have the sense that the balance is pretty right … you have to have a well-characterized risk/benefit profile.”

That stance underscores the unique position the drug industry finds itself in when it comes to regulating its products. While most sectors welcome less oversight, drugmakers say a robust review process is critical in convincing physicians and insurers that a pricey new medicine has value.

Otherwise, the time and money it takes to get a new drug to market – estimates run as high as $2.6 billion – would be lost if insurers are not willing to pay for the product.




However, there are some pharmaceutical executives calling for change, noting that any deregulation will allow them to get their products to market more quickly; that will save them money and supposedly allow them to sell prescriptions more cheaply. The idea is to allow the medications to be approved once they are deemed safe, even if they have yet to be proven effective; once that happens, the price can be increased.

Speaking as a patient, I am certainly not willing to pay for anything that has not been proven to work, no matter how safe it supposedly is, especially if my insurance company will not cover it. The only time this would make sense is in the case of life or death, if that new drug is the only remaining option. I also cannot imagine any doctors prescribing it unless those conditions are met. What would be the point of taking such a risk?

Trump has yet to name a new commissioner to the FDA, in large part because the new head will be in charge of executing these types of changes if this is what the administration decides it wants. But of course he has “a fantastic person” lined up for it. Currently it appears they have yet to decide. It is refreshing, though, that many people with the pharmaceutical industry are taking patient safety seriously enough to push back on behalf of the patients. Even though their motives may be more driven by profit, I will personally take what I can get.

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