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2018 FDA DRUG APPROVAL PROCESS: IS IT SAFE?

by Eric James Ratinoff on Aug. 10, 2018

 General Practice 

Summary: Last year was huge in U.S. Food and a Drug Administration (FDA) drug approvals, according to Drugwatch, there hasn’t been as high of a number since 1996.

Last year was huge in U.S. Food and a Drug Administration (FDA) drug approvals, according to Drugwatch, there hasn’t been as high of a number since 1996. Without including new forms of pre-existing ingredients and drugs, there were 46 new molecular entities (NME), or novel drug ingredients, that received their stamps of approval compared to the 22 that were approved in 2016.

This sped up approval process has been encouraged by President Trump’s administration, as reported in an article on Fortune. Some may argue that this accelerated pace could benefit or even save lives, but some may also point out the dangers in approval being given before confirming the capabilities and safety of the drugs.

THE RATE OF FDA DRUG APPROVALS OVER THE YEARS

According to a Research Letter published in the journal JAMA, a study was conducted to discover the average amount of time it took for a drug to be approved in a typical FDA evaluation process as well as in one of the four accelerated programs. The data was recorded between January 2012 and December 2016. Of the 174 drugs and biologic therapies approved during that time range, 69 of them took an average of eight years to be approved through the FDA evaluation process. The other 105 were evaluated through an accelerated program.

There are four different programs that the FDA uses to accelerate approval:

  1. Fast track
  2. Breakthrough therapy
  3. Accelerated approvals
  4. Priority review

Developed in 2012, the breakthrough program shaved about three years off the average eight. FDA approval was given for an average of 4.8 years or less to half of the candidates in the study. This process meant for drugs or biologic therapies that may provide “breakthrough” therapy shortens clinical trials and provides FDA staff to advise.

Fast track, installed in 1997, took off about a year in the average approval process. This program was constructed to aid in the development of drugs that fill an unmet medical need or treat serious conditions as stated in the Development and Approvals Process (Drugs)  page provided by the FDA. The benefits, though comparable, aren’t as comprehensive as the breakthrough therapies.

The last two programs accelerated approval and priority review, we’re both designed in 1992. On the FDA’s website, it is explained that the accelerated approval program expedites therapies that show promise in treating serious or life-threatening conditions and are more beneficial than other therapies already available. After gaining accelerated approval the manufacturer is required to conduct further testing to prove the drug’s benefits.

Priority review designation is given to a candidate, that if it was approved, would improve treatment, diagnosis, or prevention of a serious condition. It would then receive overall attention and resources and according to the FDA, an attempt will be made to take action on these applications within six months when standard review takes ten.

DO THESE APPROVAL PROGRAMS HELP WITH THE PROCESS?

In the Research Letter found in JAMA, the study did not show these programs shortening the average approval time.

So the question of safety remains, are these programs beneficial and life-saving or risky with the potential to be dangerous?

According to an article on Fortune magazine’s website, another study posted on JAMA found that safety risks were discovered in almost a third of the 200 drugs that had already been approved by the FDA between 2001 and 2010. Fortunately, most of the drugs only needed warning labels, but three were recalled.

New safety concerns popped up after the drug’s approval in an average of 4 years. Safety concerns can arise after a drug is already on the market since the amount of people they’re available to is much larger than the FDA trials which contain less than 1,000 people and have a time span of six months or less.

THE NEW RIGHT TO TRY ACT

Now, a new “Right to Try” act signed into law by President Trump on May 30 of this year will make the FDA’s approval unnecessary in some cases. According to an article on Ars Technica, by working with their doctor and a drug company this bill will allow patients with life-threatening diseases to use experimental therapy, that’s gone through some testing, outside of a clinical trial.

Apprehensions about cutting out the FDA’s role were raised in a post on the New England Journal of Medicine since the FDA will sometimes use data only accessible by them to guide doctors and patients in how to safely use an experimental treatment.

On the other side, this law could give people hope in the states that don’t have a similar bill enacted. Reported by an article on CNN, a senior policy advisor at the Goldwater Institute who supports right-to-try legislation, Starlee Coleman put it like this, it “is really about giving patients control over the treatments and the options that they have at the end of their life” when they have “exhausted all available treatment options and … cannot qualify for a clinical trial.”

The same could be said about the accelerated programs, although there are risks involved, the patient could be receiving potentially life-saving treatment faster.

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