Fast Track the FDA? Not So Fast…

The best-known example of birth defects being caused by hazardous substances in the UK remains the babies born in the late 1950s and early 1960s with deformities caused by their mothers taking the drug thalidomide.

It was hailed as a “wonder drug” to treat conditions such as insomnia, morning sickness and depression and licensed in the UK in 1958. But it was withdrawn again in late 1961 after an Australian doctor told the Lancet he had identified an increase in the number of deformed babies born in his hospital, and found that all of the mothers involved had used the drug.

By then around 10,000 babies had been born worldwide who either had shortened arms or legs, or no limbs at all. A few of these “thalidomide children” won damages in 1968 and the rest were covered by a 1973 out-of-court settlement with Distillers, who made the drug. Source, Denis Campbell, July 29, 2009, appearing on theguardian, US Edition (website)

 

Tuesday night, in his address to Congress, President Trump invited as his guest a college sophomore with a rare disease to illustrate why the Food and Drug Administration needs to be ripped to pieces. After 20-year-old Megan Crowley was diagnosed with the neuromuscular disorder Pompe disease as a young child, her father helped found a biotech company to develop a drug to save her.

 

“Our slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one that saved Megan’s life, from reaching those in need,” Trump said in his address. “If we slash the restraints, not just at the FDA but across our government, then we will be blessed with far more miracles like Megan.” Source, Kristen V. Brown, GIZMODO, Science…

 

Is the approval process used by the Food and Drug Administration to bring new drugs to market too slow and should it be speeded up, encouraged to cut corners, some will agree if the drugs prove to be beneficial and perform as hoped, if not, please be cognizant and proceed with extreme caution?