Sponsors to See More Costs Ahead

It is no secret that the newest leadership of the FDA has been pushing to crack down on underlying issues that had typically put the agency in a bad light and sparked criticism from the public. Most recently, the “Safe Use” program has gained discussion as a means to fixing the dangerous and unavoidable medication errors that occur in consumers.

FDA’s ideas to alleviate such accidents include regulated medication guides and improved dispensing devices, which of course equal higher costs for the drug company. While it is probably safe to assume all are on board with making drug’s and their development safer, it does not change the fact that it is an increasingly pricey business.

A CNN report quotes Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, as saying: “This new drug dosage guidance document is an example of steps that can be taken to ensure safer medication use. Many accidental overdoses result from confusion about exactly how much of a drug to take. Better measuring devices will help patients, parents, and other caregivers use the right amount of these medications—the safest and most effective dose—especially for children.”

As was recommended in the piece “Preparing for Postmarket,” it is important to know what is on the agenda for your drug’s future and to prepare as early as possible. Knowing costs early and having them worked into a budget is ideal and can only be done if these types of processes are anticipated.