The Office for Human Research Protections (OHRP) of the United States Department of Health and Human Services recently announced the availability of educational videos on YouTube for health care providers and subjects involved in clinical research. The videos currently available for viewing include "Research Use of Human Biological Specimens and Other Private Information" and "Reviewing and Reporting Unanticipated Problems and Adverse Events," in addition to two new videos "Institutional Review Board (IRB) Membership" and "General Informed Consent Requirements Parts I (Research Investigator) and II (Research Subject)."  The videos can be accessed from the OHRP YouTube playlist at http://www.youtube.com/user/USGOVHHS#g/c/5965CB14C2506914.

Use of Unapproved Contraceptive Devices Puts Both Patients and Providers at Risk 

The FDA recently issued a warning letter regarding the use by U.S. health care providers of non-FDA approved intrauterine devices (IUDs) purchased over the Internet from foreign pharmacies.  In its letter, the FDA stated that such devices are possibly dangerous, and could lead to charges of fraud.  The FDA said an investigation found that patients in Rhode Island, Massachusetts, and Kentucky had received unapproved IUDs from health care providers who had bought them from foreign pharmacies, presumably to save money. The investigation uncovered the use of unapproved versions of FDA-approved products such as Mirena, Implanon, Copper-T, and ParaGard, as well as products not approved for use in the U.S., such as T-Safe.

The FDA advised women who believe they may have received an unapproved IUD should use another contraceptive method and talk to their health care providers, and also advised physicians to use extra caution when asked to insert IUDs provided by patients. Health care providers should verify that products are authentic FDA-approved devices and were purchased from a licensed U.S.-based supplier.  The FDA also noted that billing Medicaid or private insurers for unapproved medical products could bring criminal fraud charges.  The FDA said the investigation is continuing.

We encourage our clients that do utilize these devices to review the devices they are using to assure they are FDA-approved.

If you have any questions regarding this life sciences bulletin, please contact Thomas D. Shrack at 317.338.9227 or tshrack@hallrender.com or your regular Hall Render attorney.