Heidi Alexander: “every year, Americans make nearly 3 billion trips to the drugstore, pharmacies, convenience stores to pick up…”

“every year, Americans make nearly 3 billion trips to the drugstore, pharmacies, convenience stores to pick up over-the-counter products such as allergy medicines, children's cough syrup, or simple pain medicines such as aspirin. As the Senate Health, Education, Labor, and Pensions Committee was working on the 21st Century Cures Act in 2016, I asked Janet Woodcock, the Director of the Center for Drug Evaluation and Research at the Food and Drug Administration: Are there any changes that really need to be made in the FDA's law? This is a train--referring to the 21st century cures legislation--that is likely to get to the station. If you have something that really needs to be done for the benefit of American consumers that you haven't been able to get done, tell us what it is, and we will put it on the train. Well, Ms. Woodcock, who has been at the FDA for a while, came back to me and said the over-the-counter monograph. Now, what that means is these are the rules that govern how all drugs sold in pharmacies, other than prescription drugs, are approved--the allergy medicines, the cough syrups, the simple pain medicines. Those haven't been changed since the 1970s, nearly 50 years ago. Today the Senate, after all that time, nearly a half century, will modernize these rules by passing legislation proposed by Senator Isakson and Senator Casey. It is called the Over-the-Counter Monograph Safety, Innovation and Reform Act.…”