The COVID-19 pandemic shone an unsparing light on counterfeit devices, but the FDA has previously enjoyed only limited authority to deal with those products. Thanks to legislation passed in January 2021, the agency now has authority to destroy imported counterfeit devices, including those combined with counterfeit drugs. The agency has had authority to destroy counterfeit drugs for a number of years, but that authority did not extend to counterfeit devices until passage of the Safeguarding Therapeutics Act of 2020, which was signed into law in January 2021.
The FDA’s regulation of medical technology may be assumed to have a number of unintended consequences, and one of those seems to be the lawsuit between Johnson & Johnson (J&J) and Auris Health Inc. Due to a 2018 FDA policy change regarding 510(k) devices, a robotic surgery system acquired by a J&J subsidiary from Auris was forced into the lengthier de novo premarket channel. This change ultimately helped derail the development effort for the Auris Iplatform surgical system and thus played a role in the $2.35 billion lawsuit alleging that J&J had engaged in fraud in its deal with Auris over the acquisition.
In the face of rare, sometimes fatal, side effects associated with Janssen’s COVID-19 vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend that the agency say it prefers mRNA COVID-19 vaccines over the Janssen vaccine for preventing COVID-19 in those ages 18 years and older.
Following initial approvals for rheumatic diseases, Bristol Myers Squibb Co.'s Orencia (abatacept) has become the first FDA-approved drug for the prevention of acute graft-vs.-host disease (aGVHD), in combination with calcineurin inhibitors and methotrexate, both types of immunosuppressants.
With the U.S. Securities and Exchange Commission (SEC) and Cyberspace Administration of China (CAC) imposing stricter regulatory requirements on listing companies, more Chinese companies are likely to decide to list on stock exchanges closer to home.
Clinical trial fraud has not been on the radar screen for drug and device makers in recent years, but there have been several episodes in which the operators of clinical trial sites had fabricated data for clinical trials. U.S. deputy assistant attorney general Arun Rao said recently that clinical trial fraud is now front and center for federal attorneys, raising the risk that any documentation errors for clinical trials will create a massive liability for the sponsor.
The FDA has granted approval to Urotronic Inc. for its Optilume urethral drug-coated balloon (DCB) for the treatment of male urethral strictures. The device inhibits new scar tissue growth that may form after endoscopic dilations via the controlled release of paclitaxel, an antiproliferative that inhibits scar tissue formation.
Rnaimmune Inc., which in April raised a $10 million seed round to support its discovery and development of RNAi therapies, said it is now studying the neutralizing effects of its mRNA-based COVID-19 vaccine candidate on the Omicron variant.
With 2021 coming to a close in just a few weeks, the U.S. FDA is racing to release the guidances it planned to get out the door this year. The regulator issued two draft guidances Dec. 7 detailing key clinical and production considerations to support applications for “N of 1,” or single-subject, clinical trials and drug development programs for severely debilitating or life-threatening diseases.
Two reports, one from Democrats and one from Republicans, point fingers at the reasons prescription drug prices have risen so dramatically. Both came at a time when President Joe Biden wants to change the way drug prices are determined.
RSS
