New York Bill: Patients must be Informed of FDA Recalls

Patients must be Informed of FDA Recalls

NY- Politico.com writes that pharmacies are now required by New York law to inform patients when the FDA issues recalls any of their medications. In the case of the most severe recalls such as an FDA Class 1 recall, the pharmacy has just seven days to notify the patients by phone or mail. Class 1 recalls are used when a medication can lead to severe injury or death.

The new law is designed so that patients will know when their health or safety is at risk. Patients who are informed about the dangers presented by their treatments can make more informed decisions about their medication and when to seek an alternative to their current prescription.

Prior to the signing of the law, there was no requirement for pharmacies to inform patients when their medication had been recalled. The lack of information for patients put many, including many elderly individuals, at risk of being harmed by recalled medications.

The Governor said that it only makes sense that pharmacies should have to provide the information in “real-time.”

There are around two million severe adverse drug reactions reported in the United States every year. In many cases, problems with a medication will only appear after the FDA has approved the drug and allowed it to enter the market. On average, drugs that ultimately end up being taken off the market are sold for five years in the United States before they are withdrawn.

Many drugs enter the market after being subject only to an expedited review. The expedited process, which was developed in the 1980s to allow faster development of drugs to treat HIV, is now used in many situations where it is not necessary to rush through the process. The faster review can lead to complications with new drugs going unnoticed until the drug hits the population.