On Friday January 22, CDER issued its yearly document outlining what Guidance documents it hopes to issue in 2016. This yearly wish list is always a highlight of the beginning of every calendar year. The document identifies either new guidance documents FDA hopes to release, as well as those it plans to revise. This year […]
According to a recent article in Medscape Medical News (here), the use of compounded hormone therapy to treat symptoms of menopause is a big business and accounts for a significant percentage of some compounding pharmacies income. The article provides an estimate of $1.3 -1.6 billion annually. With the flurry of FDA enforcement actions on pharmacy […]
I recently read a very interesting article about some big vitamin companies and their stock performance. I think that it deserves some attention because, when people outside of the Food and Drug Community start writing about potential problems, and when those problems translate into increased FDA enforcement actions, then Congress takes note and then (all of a sudden) laws get rewritten and regulations get passed and, the next thing you know, a segment of the industry is changed forever – or at least until the next time the government changes its mind.
As previously reported (here), Dr. Reddy’s generic of Nexium was too close to that of the innovator’s “Purple Pill”. Apparently, the firm has changed the color of its capsule and reintroduced the product. But, this does reinforce that fact that generic companies, despite the Office of Generic Drugs’ (OGD) input, desire to have the generics look more like their brand name counterparts.
FDA has given new notice to registered pharmacy outsourcing facilities that it is prepared to take aggressive enforcement action against serious violators. In one of its first major enforcement actions of 2016, a Consent Decree of Permanent Injunction was entered on January 8th against Downing Labs (formerly NuVision), a Dallas, Texas outsourcing facility manufacturing both non-sterile drug products and injectable drugs.
Not too often do you see the public gather around an idea so emphatically and in such numbers. This struck me when I was looking through the public comments on Docket FDA-2014-N-1207. To date, there are about 3000 comments posted; all are available on regulations.gov. The issue of the docket relates to the use of […]
The FDA has updated its pediatric exclusivity page (here); a search of the document reveals 9 different products received pediatric exclusivity during 2015.The number of awards of pediatric exclusivity in 2015 are substantially higher than the numbers from 2013 or 2014, when 6 awards were made in each of those years. What will 2016 bring?
Recently, FDA took administrative action by detaining at the border a product containing kratom, a plant material that may have the potential for abuse and potential serious health consequences. Then the Department of Justice filed a complaint in US District Court on behalf of the FDA “alleging, among other things, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements containing kratom are adulterated under the FD&C Act.”
I am pleased to announce that effective January 1, 2016, Frances “Fran” Zipp is President & Chief Executive Officer of Lachman Consultants.
OGD partially updated its Generic Drugs Activity Report for FY 2016 this morning and it must have found a few more receipts.
