Can Pharma Hide Side Effects Of Marketed Drugs In The U.S.?

At the end of my first year of running research at Pfizer , I drafted a year-end letter to send to all my colleagues thanking them for their hard work and dedication, and wishing them a happy and restful holiday season. As a matter of protocol, I ran the letter by the head of HR, who told me that I needed to change it. The reason was that, at the end of the letter, I said that everyone should turn off their computers, take a break from email, and relax with their families and loved ones. My HR head reminded me that some employees had to work over the holidays, specifically those whose job it was to monitor the reporting of any adverse events that might be reported for our drugs. While 99% of the R&D folks were on holiday, a small cadre of colleagues would be working over the holiday break. I changed the letter accordingly, both acknowledging and thanking those who played this important role.

I share this story because most people don’t have a clue as to the vigorous requirements put on pharma by the FDA for reporting a drug’s side effects. In fact,  when I write about the pharmaceutical industry, particularly posts that support the value that the industry adds to healthcare, I will often get attacked that I am defending an evil empire. Many believe that the industry hides negative data on its drugs. The following is typical: “Side effects should be monitored and updated and told to patients and doctors. Not hidden as they are right now.”

Actually, specific regulations exist as to how the industry must handle and report adverse events. To make sure that I had my facts right, I checked with a former colleague of mine in a pharma legal department who shared the following information. Pharma’s reporting requirements are defined in the U.S. FDA Code of Federal Regulations (21 CFR 314.80). Essentially, a U.S. Drug Manufacturer (Marketing Authorization Holder) is required to report serious, unexpected, drug related individual case safety reports within 15 calendar days of initial receipt as well as to report any follow-up information within 15 calendar days of receipt of new information.

How does a company hear of an adverse event? There are two ways. First, within the U.S., physicians and other healthcare professionals can utilize the FDA’s MedWatch Adverse Event Reporting System to report an adverse event seen with a marketed product. In addition, physicians can contact the manufacturer of the marketed drug directly by using  telephone contact numbers (toll free) and/or websites provided by the company as mandated by the FDA. Should a physician only report the adverse event to the FDA’s MedWatch program, that information is then forwarded to the drug manufacturer.

This system is not perfect as the MedWatch Program is voluntary. Thus, a physician could be derelict in reporting an adverse event. There are currently no repercussions should a physician choose not to inform  the drug manufacturer of an adverse event seen with its product. However, there may be State, County or Institutional regulations (e.g., hospital standard operating procedures) that obligate healthcare professionals to report these events.

Every pharma company has a group in its regulatory division dedicated to tracking adverse events and duly reporting these side effects both internally as well as to the FDA. This work goes on every day of the year and is taken very seriously. Contrary to the views of some of my critics, side effects are, in fact, monitored – very diligently.