Did the FDA destroy what could have been a non-addictive pain killer that might have staved off the opioid crisis before it ever stood a chance? Several decades ago, the agency approved the drug Toradol, the first non-addictive pain killer that had pain killing effects of morphine without the addictive potential. However, the FDA set the desired peak dosage, known as the loading dose, far higher than manufacturer Syntex desired. The company reluctantly complied. 97 people prescribed Toradol dies within the first few years as a result. 

With their drug no longer used in it’s original form, pharmaceutical company Syntex tried to introduce the drug in an oral form. However, the FDA overcompensated for their initial error, restricting dosage to levels not useful for medicinal applications 

Today’s guest, Charles L. Hooper worked at Syntex when Toradol was coming onto the market as a nonsteroidal anti-inflammatory drug. This was a time of excitement for the company says Hooper. They were eager to cooperate with the FDA for a successful launch.

What went wrong? Hooper discusses how a decision on something like the “loading dose” can come down to a single person, and people are fallible. The FDA’s position of final the final say had disastrous consequences, leading credence to the position that they should act as a “guiding agency. Even with all the FDA’s power and authority, nothing is a certainty.

On April 19, 2023, when asked about the opioid crisis, FDA Commissioner Robert Califf told the Senate Appropriations subcommittee it would help if pharma could develop a “non-addictive” pain medicine. “It is a tough job, but we are not successful in having nonaddictive pain medicines coming through the pipeline. We need to do everything we can do to push industry and make this happen.”

 
Learn more here: FDA Commissioner Called Out for Remark on Non-Addictive Painkillers

Read Charles Hooper’s article in the Wall Street Journal for more: How the FDA Helped Fuel the Opioid Epidemic