Drug Companies Not Allowed to Engage in Off-label Promotion. FDA Website Allows Consumers to Report Misconduct, Device Malfunctions.
Patients can now report allegations of regulatory misconduct and medical device malfunctions directly to the U.S. Food and Drug Administration (FDA) through a new website.
Consumers can report misconduct such as off-label marketing, in which a manufacturer promotes their product for a use not approved by the FDA. Parker Waichman drug injury attorneys note that doctors are allowed to prescribe drugs off-label but it is illegal for drug companies to engage in off-label promotion.
The public can also report instances where a device maker failed to warn about safety risks associated with a certain product as mandated by federal regulations.The new website “was developed to provide the public with more information on allegations of regulatory misconduct related to medical devices and provide clear instructions for reporting to the FDA” an agency spokeswoman said, according to Star Tribune.
The regulators state that “reporting allegations can help make the FDA aware of regulatory concerns it may not learn of otherwise.”
“This information can help the FDA identify the potential risks to patients and determine whether further investigation is warranted, as well as any steps needed to address or correct a potential violation.”
The webpage also provides an opportunity for the public to report manufacturing processes that fail to meet government standards, regulatory issues and efforts to hide safety information from regulators. The FDA may inspect facilities, issue warning letters or recalls in response, an FDA spokeswoman said to Star Tribune.
The initiative was praised by Sen. Amy Klobuchar of Minnesota, who said the site has “potential to strengthen oversight and safety of medical devices.” Star Tribune reports. “All patients deserve to know the risks and side effects of a medical procedure and a medical device in order to make informed decisions about their care,” Sen. Klobuchar said.
Patient advocates and health researchers agree that the website is a positive step, providing a convenient route that allows the FDA to quickly identify misconduct. The success, however, will depend on enforcement, they say. Diana Zuckerman, president of the National Center for Health Research, commented
“This is a good idea, but the question is: what resources will the Center [for Devices and Radiological Health] devote to this to ensure that the allegations of misconduct are followed up and dealt with accordingly?”
Similarly, Dr. Michael Carome, director of Public Citizen’s health research group, noted that the website “will be insufficient unless the agency appropriately investigates … and takes robust enforcement actions against companies that place patients at risk.”
FDA Investigation Finds Hospitals Under-Reporting Adverse Events
The FDA said it was looking for ways to improve reporting among hospitals after its own investigation showed that some hospitals underreported adverse events with power morcellators and duodenoscopes, devices that came under public scrutiny due to safety concerns.
Power morcellators, which are used to dice up tissue during gynecologic procedures, were found to spread hidden cancers. Duodenoscopes are devices are snaked into the first portion of the small intestine; they were linked to an outbreak of “superbugs” at various US hospitals. Federal regulations require hospitals and manufacturers to report adverse events associated with medical devices.
In light of the morcellator and duodenoscope fiascos, the FDA conducted an investigation last December to test whether injuries and deaths were being accurately reported. According to a blog post written by Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, a probe of 17 hospitals that had issues with morcellators or contaminated duodenoscopes found “little to no reporting” of adverse events. The FDA said it was looking to improve how hospitals report medical device injuries in response to these findings.
The inadequate reporting involved various factors, including hospital staff training, knowledge and lack of a reporting system. Shuren says that oftentimes, staff either were not aware of reporting requirements or were not trained in how to comply. Some hospitals did not even have a system set up for staff to report medical device problems.
The investigation leads researchers to believe that the problem may be widespread. “Based on the number of user facilities in the United States and the number of reports we receive, we believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals,”
Duodenoscope makers Olympus, Pentax and Fujifilm received an FDA warning letter last August citing failure to warn about the risk of contamination with the specialized scopes, which are used to treat problems with the pancreas and bile duct. In some cases, the agency said manufacturers failed to make sure the scopes were effectively cleaned. Contaminated duodenoscopes were linked to an outbreak of infections with antibiotic-resistant bacteria starting in 2012.
Lawmakers Propose New Regulations Due to Power Morcellators, Essure
Lawmakers are also making efforts to implement stricter reporting requirements. Representative Mike Fitzpatrick introduced the “Medical Device Guardian’s Act” following delayed awareness surrounding power morcellators. The device was believed to hold an extremely slim chance of spreading a hidden cancer, but the medical literature showed otherwise.
In 2014, the FDA warned that the risk is present in 1 in 350 women. Fitzpatrick and other sponsors of the bill emphasized that the problem was not identified until a patient, a husband-and-wife physician couple who experienced the problem firsthand, brought their story into the public sphere in 2013.
The proposed regulation would require doctors to report medical device injuries and deaths to the FDA; this is already required when it comes to drugs, but currently only hospitals and manufacturers must report medical device injuries. The bill would also prevent the reports from being used against physicians in court.
Fitzpatrick has also introduced Ariel Grace’s Law, which was fueled by concerns over Essure, Bayer’s permanent birth control device. The legislation would make it easier for patients to sue over Essure injuries and get the device off the market.
Essure consists of two metal springs inserted into the fallopian tubes to prevent fertilization. Alleged adverse events include abdominal pain, menstrual irregularity, headaches, fatigue and other complications. Additionally, some women have reported getting pregnant despite the procedure and suffering miscarriages.