A Quote by Dilip Shanghvi
I think FDA's concerns are patient-safety.
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When the FDA forces an old drug off the market, patients have very little say in the matter. Patients have even less of a say when the FDA chooses not to approve a new drug. Instead, we are supposed to rely on the FDA's judgment and be grateful. But can the FDA really make a choice that is appropriate for everyone? Of course not.
Food safety oversight is largely, but not exclusively, divided between two agencies, the FDA and the USDA. The USDA mostly oversees meat and poultry; the FDA mostly handles everything else, including pet food and animal feed. Although this division of responsibility means that the FDA is responsible for 80% of the food supply, it only gets 20% of the federal budget for this purpose. In contrast, the USDA gets 80% of the budget for 20% of the foods. This uneven distribution is the result of a little history and a lot of politics.
FDA, which regulates the safety of vegetables, doesn't have those kinds of rules because Congress doesn't want it to. It's not that the vegetables themselves have anything wrong with them; it's that they're contaminated with animal manure. One of the rationales for a single food safety agency is that you can't separate animals from vegetables.
The thing that bugs me is that the people think the FDA is protecting them - it isn’t. What the FDA is doing and what the public thinks it’s doing are as different as night and day.
People think the FDA is protecting them -- it isn't. What the FDA is doing, and what people think it's doing, are as different as night and day.
Some of the FDA's own scientists have charged that politics, not science, is behind the FDA's actions.
The FDA is redefining birth control as abortion. The FDA is setting the bar higher for this kind of drug.
Increasing patient access to more affordable, FDA-approved generic and biosimilar medicines is a proven and tested solution to lowering prescription drug costs.
The public properly relies upon FDA classification of drugs as nonprescription as a reflection of the agency's judgment regarding the safety and proper use of a drug without a doctor's prescription.
I think every doctor should know the shocking state of affairs...We discovered they (the FDA) failed to effectively regulate the large manufacturers and powerful interests while recklessly persecuting the small manufacturers. ...(The FDA is) harassing (small) manufacturers and doctors...(and) betrays the public trust.
I think if the doctor is a good doctor and has a patient's best interest in mind then he's not going to allow anything to compromise that patient's care. The bottom line is the doctor has to care for his patient. You have to have that overwhelming sense of welfare for your patient.
Safety concerns are reasonable. Banning refugees is certainly not.
If these restrictions were necessary, the FDA would have promulgated them in the first place, the FDA knows how to evaluate scientific information. Congress knows nothing about that.
By law and institutional culture, FDA seeks to apply a single tool to its approach to regulation - the requirement for pre-market approval. The agency is accustomed to compelling innovators to submit evidence to FDA and seek permission for marketing.
Since I didn't grow up going to school dances, etc., I didn't have the normal . . . I grew up in a very different way so a lot of the childish concerns or teenage concerns weren't my concerns. My concerns were survival.
I think that the FDA has not been able to catch some of these things as quickly as I expect them to catch and so we’re going to be doing a complete review of FDA operations. At bare minimum, we should be able to count on our government keeping our kids safe when they eat peanut butter. That’s what Sasha eats for lunch. Probably three times a week...
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