A federal judge ruled earlier this month that the Food and Drug Administration can't bar a drug company from promoting an unapproved use for its pills derived from fish oil, The Washington Post's Carolyn Johnson reports. U.S. District Judge Paul Engelmayer ruled that the First Amendment protects Amarin Corp. "'truthful and non-misleading speech'" in promoting a use of its pills that has not been approved by federal regulators.
According to a report in iHealthBeat, the Food and Drug Administration is going to expand a pilot that is using electronic health records, as well as claims data, to monitor the safety of medical devices the agency regulates: "Specifically, FDA said the [Mini-Sentinel] system can examine: More than 350 million person years of observation; Four billion pharmaceutical dispensings; and 4.1 billion patient meetings." Now, the pilot is being rolled out on a full scale.
U.S. Senators Michael Bennett and Orrin Hatch are circulating a draft bill to exempt some electronic health records, including medical charts and health histories, from the FDA's oversight, Reuters' Christina Farr reported last week. Medical technology that is classified as posing a low risk to patient safety would be exempt from FDA regulation. Bradley Merrill Thompson, an FDA-specialist with the Washington D.C.-based legal firm Epstein Becker & Green, told Reuters the bill would have unintended consequences.
What if hackers caused medical devices to malfunction? Disrupted healthcare services? Accessed patient information or electronic health record data? Those are examples of potential digital security pitfalls for the healthcare industry. Here's a piece I wrote for the National Law Journal about the need to develop industry standards for cybersecurity for medical devices and other health information technology:
A cybersecurity framework for medical devices and health-care technology needs to be developed in a partnership between the government, manufacturers and health-care providers, officials from across the public and private sectors during a workshop convened by the U.S. Food and Drug Administration.
“Right now, for cybersecurity, we’re all in a reactive mode,” said Deborah Kobza, executive director of the National Healthcare Information Sharing and Analysis Center. “We need to change that to be in a preventive mode.”
The concern is that hackers could cause medical devices to malfunction, disrupt health-care services or steal patient information and electronic health records. The FDA, along with the Department of Health and Human Services and the Department of Homeland Security, sponsored the two-day workshop this week.
The Advanced Medical Technology Association’s Jeffrey Secunda said that, “for devices that are facing the Internet, you do have the risk of advanced persistent threats.”
How the FDA is going to approach cybersecurity, including evidence that devices have led to patient harm, “is exactly why we’re convening this meeting,” said Suzanne Schwartz, director of the FDA’s emergency preparedness/operations and medical countermeasures in the Center for Devices and Radiological Health.
Workshop participants said they were unsure how much tolerance there is for the risk that patients information could be breached in the effort to make electronic health records and health information technology “interoperable” and more accessible to patients.
Dr. William Maisel, the FDA’s chief scientist and deputy center director for science at CDRH, said there are 100,000 medical devices on the market and the technology changes rapidly. The FDA doesn’t view it as a solution to take in all the information about digital security vulnerabilities in medical devices and pass it on to the community, he said.
Instead, federal regulators want an “ecosystem where that information is being shared,” such safe harbors for medical device manufacturers and health-care providers to make reports about cybersecurity breaches without incurring liability, he said.
Participants said that providers don’t report digital security breaches for fear or exposure during litigation.
The National Healthcare Information Sharing and Analysis Center’s Kobza noted that her group has entered a memorandum of understanding with the FDA to develop a protocol about sharing information about medical devices.
David Hoffman, writing in a Washington Post opinion piece, notes that the Food and Drug Administration has long wanted to curb the use of antibiotics on farms out of the concern that their overuse will make bactera resistant to the drugs. The agricultural industry has pushed back, especially regarding the use of tetracyclines, antibiotics that are not used in humans as much as it is used in animals. Hoffman notes that "research, by a team that included H. Morgan Scott of Texas A&M University and Guy Loneragan of Texas Tech University, showed that the use of a tetracycline led to 'co-selection,' a process in which the antibiotic expanded the population of bacteria that are resistant to otherantibiotics as well." The FDA now has asked drugmakers to voluntarily stop producing antibiotics for growth promotion and all have agreed. The FDA also will require antibiotic use in livestock to be supervised by veterinarians.
A federal judge ruled that a Massachusetts state ban on the sale of prescription painkiller Zohydro violates federal law, Reuters reports. Governor Deval Patrick had banned the drug when declaring a public health emergency about the abuse of opoids in his state. But Judge Rya Zobel ruled that the ban interferes with the Food and Drug Administration's "constitutionally mandated" regulatory authority, Reuters also reports.
Information technology is changing health care. Federal regulators are looking to draft rules to protect patient safety in this new landscape.
The Food and Drug Administration is trying to draw up a framework for the FDA, the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology to regulate information technology related to medical devices, electronic health records, and other health IT, the Washington Post reports.
The recent report on the plan is out for public comment and "signals that the FDA might pursue a loose regulatory framework for some elements of health-care IT, allowing technologists to innovate without being burdened by federal oversight, said Gartner analyst Wes Rishel," the Post further reports.
ProPublica and This American Life put together a pretty amazing reporting project about how 150 Americans die every year by taking too much acetaminophen, Tylenol's active ingredient, and that there were decades-long delays in providing updated consumer warnings that using too much of over-the-counter painkillers with acetaminophen could lead to liver toxicity and even death. This spring, I reported for The Legal Intelligencer that a federal multidistrict litigation for plaintiffs who allege that their use of over-the-counter Tylenol caused their livers to fail or be poisoned was approved to be presided in front of U.S. District Judge Lawrence F. Stengel of the Eastern District of Pennsylvania: http://www.law.com/jsp/pa/PubArticlePA.jsp?id=1202594695498&slreturn=201...
Many more cases may be generated in the MDL in light of this reporting project.
If you haven't read and/or listened to ProPublica and This American Life's reportage, here it is:
http://www.propublica.org/article/tylenol-mcneil-fda-kids-dose-of-confusion
http://www.propublica.org/article/tylenol-mcneil-fda-use-only-as-directed
http://www.thisamericanlife.org/radio-archives/episode/505/use-only-as-d...
Read more: http://www.law.com/jsp/pa/PubArticlePA.jsp?id=1202594695498&slreturn=201...
http://www.law.com/jsp/pa/PubArticlePA.jsp?id=1202594695498&slreturn=201...
Lawyer and Legal Journalist
