Drug companies know how to play the FDA drug approval process


  • The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs.
  • The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process.
  • The FDA has been under criticism, but an internal investigation will focus on approval processes, not “why” a drug was approved.
  • Our healthcare system cannot continue to support marginally effective drugs. We need to learn to say NO.
  • Drug companies know how to play the system.

The FDA approves an Alzheimer’s drug with questionable data yet asks for more data from Pfizer on a COVID booster shot. Can we make sense of this? A study published in JAMA Internal Medicine found that among cancer drugs that received accelerated approval from the FDA using surrogate endpoints or other measures, only one-fifth ended up improving overall survival rates in later confirmatory trials. Yet review delays for JAK inhibitors, some of which are seeking label expansions. Why?

It seems that if a drug, seeking approval, has the possibility to improve or save just one life, it stands a great chance of being approved. However, if a drug is not life-saving, the FDA wants more data and, in some cases, a lot more data. IMO drug companies know this and play the system with data that is often incomplete.

In some cases, drug companies seek additional approvals for an existing drug to expand their use and make more money. It’s no coincidence that drug companies’ stock speculators bet on expanded approvals for either a buy or sell recommendation.

The FDA has been under a lot of criticism following the approval of Biogen’s drug, and although Ms. Woodcock has called for an investigation of itself, the issue is not the process that decided the fate of this drug; it’s the data behind the approval that’s been in question. We know Alzheimer’s is a horrible disease and that it takes a toll on both patients and caregivers, but if there is one chance in a thousand that the drug can help someone, the FDA thought it worth the risk. The issue continues to be “do patients, and caregivers understand the risk?”.

Given what’s happened around the approval, for use, of certain drugs around COVID and the media coverage one has to wonder of the public and, more importantly, HCPs trust the FDA to do what’s right. The FDA, when approving drugs, doesn’t take into account costs like some healthcare systems in Europe. Maybe they should.

According a report released by the National Academy of Medicine, Medicare pays for three-quarters of drug-based cancer treatment for seniors, and many cancer drugs have prices that are rising far faster than the cost of drugs and medical care in general. Should they pay for all of them without data that shows it extends with the quality and quantity of cancer patients?

STAT News reported, “a new study finds that prices for dozens of cancer medicines were substantially higher when introduced into the U.S. market compared with three wealthy European countries — and they continued to climb at a rate faster than inflation over a decade. That is unacceptable and unsustainable..”

According to a 2019 survey conducted by The Mesothelioma Center at Asbestos.com, 63% of cancer patients and loved ones reported financial struggles following a cancer diagnosis while drug companies spend billions in stock buybacks. That says enough.

Our healthcare system cannot continue to support marginally effective drugs or expand labels of drugs with safety issues. Drug companies are playing the system as any good business in search of profits would do.