BAM! Traffic has returned. So have we all from the beach or the mountains or somewhere in between. Back-to and First-Day-of-school pictures have dominated Facebook postings. A promise has been extended by weather folks that the high temperatures and humidity will both drop. Hurricanes have begun spinning their way across the Atlantic – and in political news. I took last week off for the end of summer and a birthday and so this week will incorporate a few things that happened from last week. And next week there will be postings between the Weekly Roundups as we get back to a more normal routine. So here is a bit of what happened.
- OPDP Issues Fourth Letter of the Year – Yes, the rest of us were on vacation, but the eerily quiet Office of Prescription Drug Promotion (OPDP) was not and the agency posted the fourth letter of the year that had been sent out mid-month. The letter was an Untitled Letter and as has become the near-norm, it went to a company that you would not find in the top-50 list of companies in terms of size. The product in question is indicated for treatment of moderate to severe vasomotor symptoms and moderate to severe vulvar and vaginal atrophy due to menopause and was a topical gel that came with a boxed warning on the label, but the agency made no mention of risk in the violation portion of the letter. The communications vehicle in question was a “sell sheet” that contained language that the product represented the treatment with the “lowest effective dose” for the indicated uses when FDA said that this was not the case. You can see the letter and sell sheet here. Unsubstantiated claims are a relatively rare violation.
- Sweet Spot on Sugar – Finding the best way to design the nutrition label on the food we purchase is the product of a long and negotiated effort. This week FDA Commissioner Scott Gottlieb issued a statement to discuss the treatment of “added sugars” and what that means. He stated that while the old version of the label listed only the total grams of sugar without distinguishing between naturally occurring sugars and those that are added to the product, the new final rule does and includes not only sugar, but honey and maple syrup among others, noting that added sugars can contribute more than 10 percent of a person’s daily calorie intake. The new label will not only note the added sugar, but will include an added daily value for added sugar for the consumer to make assessments. However that may be confusing when the product is a single ingredient product such as syrup or honey. For those type of products then as of now FDA is suggesting the label include extra information to clarify any reference to “added sugar” to be included in a sort of footnote so as not to confuse consumers. FDA anticipates issuing the final guidance by January 2020.
- Compounding (Again) – The agency announced that it was issuing a revised draft of the Memorandum of Understanding (MOU) between FDA and the states to address outstanding issues related to the regulation of compounded drugs, taking steps to address concerns that have been raised by pharmacies regarding a 2015 draft. The concerns raised centered on the potential for restrictive distribution policies laid out would impede patient access to compounded drugs for which there is a legitimate medical need. FDA liberalized the provision that was of concern in a way that would allow more compounding pharmacists to distribute compounded drugs. The agency also signaled that in the coming months there would be several more actions in relation to compounding to shore up safety with regard to their development and use and cited as an example the existence of unsanitary conditions in settings were drugs are produced.
Things to Keep an Eye on This Week
- September 12 – Workshop – Regulatory Education for Industry – Complex Generic Drug Development
- September 12 – AdComm – Pharmacy Compounding Advisory Committee
Regulatory Developments in Pharma/Biotech/Devices
- FDA launching new program to review moderate risk devices
- FDA launches pilot program to advance innovative clinical trial designs
- Public meeting set by FDA to examine drug shortage causes
- Comment period on development of gene therapy products extended