A panel of the US Food and Drug Administration (FDA) has voted to switch to electronic prescribing for alosetron hydrochloride in addition to retaining
The RESULTS are in!
A panel of the US Food and Drug Administration (FDA) has voted to switch to electronic prescribing for alosetron hydrochloride in addition to retaining and refining other aspects of the current risk management system that restricts its availability.
Alosetron hydrochloride (LOTRONEX), manufactured by Prometheus Laboratories, Inc, is the only drug that is currently available for the treatment of women with severe diarrhea-predominant irritable bowel syndrome (IBS-D) who have not responded well to conventional therapies. Significant risks are associated with the use of this drug including ischemic colitis (inflammation and injury to large intestine resulting from inadequate blood supply), bowel perforation and ileus (bowel obstruction).
Members of the FDA’s Drug Safety and Risk Management Advisory Committee reiterated the importance of provider-patient communication about both the risks and benefits of the drug. Many expressed a desire to collect electronic data within the current Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (ETASU) to assure compliance and monitor patient improvements.
In the current REMS/ETASU, only certified physicians are able to write prescriptions for alosetron. These certified individuals must write the prescription on paper then affix a sticker to it to attest that they are certified and the patient follows under the appropriate criteria. These criteria ensure that alosetron is used only in severely affected patients where the benefits would exceed the risks. For the pharmacy, REMS/ETASU for alosetron stipulates that only paper prescriptions with the sticker be filed. Fax, phone and computer prescriptions are not allowed.
The advisory panel discussed a variety of options for revising REMS/ETASU. All members were in favor of eliminating the sticker requirement and beginning e-prescribing as soon as possible. In addition, most of the panel favored keeping the requirement where patients sign a form attesting that the physician discussed the benefits and risks of the drug and that they fully understood the information. Some of the panel also endorsed the idea of an electronic registry.
Dr. Woods, clinical coordinator and residency program director in the Pharmacy Department at Saint Luke’s Hospital, Kansas City, Missouri, noted that it is necessary to ensure that any new electronic system implemented must still portray the special circumstances and conditions for which this drug is prescribed. “The sticker did serve a purpose. It communicates to the pharmacist that this is not the usual prescription. We have to have mechanisms so that everybody who’s taking care of that patient knows that this is a special circumstance.”
ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact email@example.com.
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more
One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us todayContact us