Perhaps that could change. At his confirmation hearing, Makary told senators he planned to evaluate school lunches, seed oils, and food dyes. “Maybe three years from now the FDA will change and have much more of a food focus,” says Robertson.
The pair also write that they want to speed up the process of approving new drugs, which can currently take more than 10 years. Their suggestions include allowing drug developers to submit final paperwork early, while testing is still underway, and getting rid of “recipes” that strictly limit what manufacturers can put in infant formula.
Here’s where things get a little more controversial. Most new drugs fail. They might look very promising in cells in a dish, or even in animals. They might look safe enough in a small phase I study in humans. But after that, large-scale human studies reveal plenty of drugs to be either ineffective, unsafe, or both.
Speeding up the drug approval process might mean some of these failures aren’t noticed until a drug is already being sold and prescribed. Even preparing paperwork ahead of time might result in a huge waste of time and money for both drug developers and the FDA if that drug later fails its final round of testing, says Robertson.
And as for infant formula recipes, they are in place for a reason: because we know they’re safe. Loosening that requirement might allow for more innovation. It could lead to the development of better recipes. But, as Robertson points out, innovation is a double-edged sword. “Some innovation saves lives; some innovation kills people,” he says.
Along the same lines, the pair also advocate for reducing the number of clinical trials required for the FDA to approve a drug. Instead of two “pivotal” clinical trials, drugmakers might only need to complete one, they suggest.
