The chives have poked their way up through the winter refuse of leaves and dried stems letting me know it is time to get the garden beds all ready again for Spring and to even be so optimistic as to begin some cautious planting. I fully believe that one day I will have my little farm that I want, but in the meantime, a small back yard that despite its size still overwhelms me, will have to do. In any case, welcome Spring!
And as we prepare ourselves for outdoor labors, here is some of what happened indoors that was interesting this week:
- FDA Settles “Off-Label” Lawsuit – A long-standing lawsuit regarding corporate speech and off-label discussion of products made the news this week when FDA and the company involved arrived at a settlement. The lawsuit involved a company aiming to use truthful and accurate communication to discuss its product even where the discussion involved an off-label use. A lower court had ruled that FDA could not prohibit such communication. In the settlement it was reported that FDA agreed to circumstances whereby the company could promote an off-label use where the promotion was truthful and not misleading. Despite the fact that the settlement only applies to the company in the lawsuit, it does necessarily beg the questions whether the agency will eventually reconsider its approach to this issue. You can read media coverage of this here.
- Another DTC Study – Last week it was noted in The Weekly Roundup that FDA was seeking input on a study that the agency would undertake regarding the impact of the use of animation in DTC ads. This week there is another chapter, indicating a broader assessment of DTC advertising, as FDA announced that it was also seeking input into the use of superimposed text and its impact on consumer comprehension. On a related note, all the study would be for naught if Senator Al Franken gets his way – having introduced legislation this week to deny the tax deduction available to companies engaged in RX DTC advertising.
- Guidance Galore – This week FDA issued a number of guidance documents. One was a final guidance intended to provide the agency’s outlook on how stakeholders can reduce the amount of acrylamide in food. The agency also released a guidance document on Investigating and Reporting Adverse Reactions to Human Cells, Tissue and Other Cellular and Tissue-Based Products. Finally also this week FDA issued a draft guidance on evaluating respiratory symptoms in Chronic Obstructive Pulmonary Disorder and use of patient reported outcomes.
Off to the garden beds! Have a great weekend everyone.
