After finding that the N-nitrosodimethylamine (NDMA) impurity in some ranitidine (Zantac) drugs increases over time and when stored at higher than room temperature, the FDA Wednesday asked manufacturers to immediately withdraw all prescription and over-the-counter ranitidine products from the U.S. market. The NDMA increases in the heartburn drugs over time may result in consumer exposure to unacceptable daily levels of the impurity, which is considered a probable human carcinogen. “We didn't observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don't know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. The FDA last year became aware of independent laboratory testing that found NDMA in the heartburn drugs. The agency’s initial tests found NDMA at low levels in the drugs. But new FDA testing and evaluation, prompted by information from third-party laboratories, confirmed that the NDMA levels increase in ranitidine even under normal storage conditions, Woodcock said, adding that the levels increased significantly in samples stored at higher temperatures, including temperatures the drugs may be exposed to during distribution and handling by consumers. The testing also showed that the older a ranitidine product is, the greater the level of NDMA. Besides notifying manufacturers, the FDA is advising consumers to immediately stop taking ranitidine drugs and to properly dispose of any they currently have.
The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued guidance April 1 on regulatory flexibilities it’s adopting to support the drug supply chain and the wider health care response to the COVID-19 outbreak. The flexibilities are temporary and effective immediately, the agency said. Under the guidance, the MHRA committed to expedited scientific advice for clinical trials and rapid reviews of trial applications involving potential COVID-19 treatments. It also is replacing most routine onsite inspections with desk-based inspections, permitting the “pack down” of large packs of drugs into smaller quantities for sale at pharmacies, expediting the assessment of variations and initial applications that impact the drug supply chain, and extending the deadline for step 1 nitrosamine responses by six months, to Oct. 1, 2020. The agency also may implement reduced retesting of imported products under certain circumstances.
The FDA, in collaboration with other federal agencies and the Institute for Genome Sciences at the University of Maryland, developed quality-controlled reference sequence data for the SARS-CoV-2 reference strain for the U.S. The availability of traceable and quality-controlled data will help COVID-19 test developers and vaccine developers expedite the development of medical countermeasures, identify new or more stable targets for future tests, enable in silico confirmation of targets, support the development of synthetic reference material and enable viral population/quasi species analysis, the agency said.
Recognizing the hardships COVID-19 has imposed, the U.S. Patent and Trademark Office (USPTO) on March 31 extended the deadlines for filing certain patent documents and paying some required fees. “We are working to provide as much relief as possible to our stakeholders, consistent with our ability to maintain the USPTO’s fee-funded operations,” USPTO Director Andrei Iancu said. “We are especially mindful of the outsized impact on small businesses and independent inventors, and have provided additional relief for these groups. Ultimately, our goal is to ensure not only that inventors and entrepreneurs can weather the storm, but that they can hit the ground running once it passes.” Other steps the agency has taken due to the emergency include replacing in-person hearings and examiner interviews with virtual meetings.
The EMA increased its general, nonpharmacovigilance fees by 1.6%, effective April 1, in line with the 2019 inflation rate published by Eurostat. All EMA applications received after March 31 will be charged the adjusted fees. The cutoff point for scientific advice and protocol assistance will be the date the request for advice is validated. For annual fees, the new rate will apply at the time of an anniversary date of the decision granting marketing authorization that falls after March 31. In addition to the increased rate, the EMA has set new fees for consultations on medical devices and for assessments.