Welcome to the first Weekly Roundup of the year! The fact that it was a short week and one in which the East Coast and a good deal of the South were experiencing a weather challenge means that there was not as much action as might otherwise be happening. But I am taking advantage of the rather slow week to make a few observations as we make the transition from the sleepy holiday time to our regular course of business as well as providing the latest out of FDA.
- Commissioner Announces New Steps to Speed Generics – In what has been a regular event now, Commissioner Gottlieb issued a media statement outlining new steps to enhance review of generic drugs that are part of the Drug Competition Action Plan announced in June, 2017. The new steps being announced are in relation to one of the three goals of that plan – to improve the efficiency and predictability of the review process in order to reduce the time of the review and lessen the number of review cycles that the company must go through in applying. To that end, the agency issued a draft guidance entitled “Good ANDA Submission Practices” to review common deficiencies in applications for prospective applicants. In addition, the agency issued a companion piece for staff in the Manual of Policies and Procedures (MAPP) that was intended to formalize a more streamlined process from the staff side. During confirmation hearings one area of concern voiced by several policymakers was the cost of pharmaceuticals. While FDA is limited in what it can do on pricing, the swift approval of generics is one means to bring down costs and Commissioner Gottlieb noted that FDA took action on more applications in the last six months of 2017 than in any other 6-month period in the agency’s history.
- OPDP Issues Warning Letter – With the close of 2018, enforcement by OPDP as expressed by the issuance of Warning or Untitled letters hit an all time low after trending lower the past few years. While it is still possible for a 2017 letter to be posted, in mid-December FDA issued its fourth letter of the year. The letter was a Warning Letter and the subject was an Exhibit panel used to convey information about a weight loss treatment in medical meetings where risk information was not included despite several risks and restrictions in the label of the product. It is the second letter of the year addressing an Exhibit Panel and the second letter of the year for a weight loss treatment. The letter can be found here. Also consistent with an on-going trend, all four of the letters were addressed to companies not in the top 50 list of pharmas.
- AdComm Schedules – The new year begins with four advisory meetings currently scheduled beginning as soon as next week (see below for the most immediate). The FDA added the new 2018 Advisory Committee Tentative Meetings Page on the agency website, but did not list any potential dates for meetings. In years gone by, FDA would post the entire calendar year’s worth of tentative dates so that one could see where each committee was planning – at least tentatively – to have a meeting and thereby giving the panel members, and us, the ability to plan. It appears now, however, that the future dates are not being carved out. In fact, even though there are some committees already slated to meet, for CDER this page is now failing to mention even those dates. In short, this page no longer appears to have any relevance over the more up-to-date page of FDA Scheduled Advisory Committee Meetings.
Upcoming Events to Keep an Eye on This Week
- Full Senate HELP Committee Meeting – The Opioid Crisis: An Examination of How We Got Here and How We Move Forward – Tuesday January 9.
- January 9 and 10 – Meetings of Bone, Reproductive and Urologic Drugs Advisory Committee Meeting – to consider two NDAs, both oral testosterone replacement therapies – January 9 here, and January 10 here.
- January 11 – Meeting of the Anti-Microbial Drugs Advisory Committee – to consider NDA for treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.
Regulatory Developments in Pharma/Biotech/Devices
- Breakthrough Therapy Status for initial endocrine based treatment in pre-menopausal women with HR+/HER2- advanced breast cancer
- Breakthrough Therapy Status for treatment for severe aplastic anemia (SAA)
Photograph courtesy of Robert Barrett
