Today we remember those lost, honor those living who were there to help and dedicate ourselves to a goal of peace.
Here is a bit of what happened this past week that I thought noteworthy:
- NIH Announces Landmark Blood Pressure Study - A study that is sure to spark conversations and new scripts for blood pressure medication was released this week by NIH. The importance of the study – called SPRINT – lay in the fact that it would appear that more aggressive control over blood pressure levels might result in better outcomes for patients, particularly those over 50. Hypertension, a very common condition, is known to have several ill effects on the body. Looking at the systolic figure, when the SPRINT study was designed, the standard for control was 140 in healthy adults and 130 in those with kidney disease. The study suggests a target of 120 or less brings added health benefits.
- FDA Advances Food Safety Measures – And speaking of landmark, FDA announced this week that it was taking “one of the most significant steps in decades” in food safety by finalizing the first two of seven major rules under the Food Safety Modernization Act. The effort is aimed at prevention and according to the agency will result in holding imported food to the same safety standards as food that is produced domestically and develops a nationally integrated food safety partnership between the federal government and states. The ultimate goal is to work to prevent outbreaks rather than be in a position of responding to an outbreak once it has occurred. The announcement states that the action will affect both human and animal food.
- FDA to Look at Hormonal Contraception Drug Interactions - The agency announced the scheduling of a public meeting to be held November 9, 2015 at the FDA White Oak Campus site entitled “Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implications”. FDA states that the goal of the meeting is to gain input on the public health concerns associated with the use of horomonal contraceptives and interacting drugs. People interested in attending the meeting in person or via Internet are directed by FDA to register by October 9. The docket for comments will be open until December 15.
That’s it for this week. Have a good weekend everyone.
I missed the Weekly Roundup last week while on vacay and took this week off from blogging because let’s face it, everyone is gone. We are at that special cusp when the calendar really does coincide with a noticeable change in the environment. September – just before the chill comes – the growing season is tired. You can see it in the leaves, brown and curling at the edges. They are anxious to turn colors and fall off. Everything has an overly dry look. The season is a bit tired. Soon the barbeque grill will be left in favor of the fireplace. Sweaters will come out. Linens will go away.
In spite of the fact that the nation is away, a few interesting things did happen these past few weeks and here they are.
- Kardashian Reposts On Morning Sickness – Everyone is aware of the hoopla that resulted when a spokesperson for a morning sickness medication, Kim Kardashian, posted on Instagram commentary about the morning sickeness drug DICLEGIS which got FDA’s attention and response in the form of a warning letter due to the lack of risk information in the posting. FDA provided a link to images of the original material here. This past week, there was a re-posting of the material, this time with risk information included.
- Caffeine Warnings - FDA issued a round of Warning Letters dated August 27 to supplement manufacturers over the marketing of powdered caffeine products. The packaging of the product was such that consumers were many times instructed to measure out very small amounts of the powder (e.g., 1/14th of a teaspoon) which would require the use of equipment not often found in the possession of a typical consumer. FDA points out that an entire teaspoon of the powdered product could have harmful effects as it would offer the equivalent of 28 cups of coffee.
- E&C Letter to FDA on Blood Thinner Warfarin – Congress may be on recess, but a letter went out this week from the House Energy and Commerce Committee to Acting FDA Commissioner Dr. Stephen Ostroff following a report on adverse events often experienced in association with the use of the drug in nursing homes. Recognizing the fact that FDA did not have jurisdiction over nursing homes, the committee was nevertheless seeking to understand FDA’s awareness of the issue and whether or not any steps could be taken to mitigate the adverse events.
Enjoy the last “summer” weekend. We will be back next week and I will be providing some more updates on the database of pharma use of social media. Until then, take care.
We are at the end of summer. Though not young, my mental calendar is still locked into the mentality regarding the beginning of school. This is the last week to relax before the onslaught of back to school, days full of classes, new people to meet, new subjects to explore. And of course, the coming of Autumn. But first, the last, lazy days to spend at the beach, at cookouts and driving in days that are low in rush-hour traffic.
On that note, I will be taking next week as a end of summer holiday week – so unless something extraordinary happens, there won’t be any postings. However, I will be working on a few things that I hope will interest you when we are “back to school” and in the swing of things.
FDA it seems has already been on vacation – it has been a slow August, but a few items of note:
- Approval for HSDD Drug for Women – Here it is. There has been a long quest to bring to market a drug for women affected by hypoactive sexual desire disorder (HSDD). Back in June, we reported on the Advisory Committee being held to consider approval, having voted 18-6 in favor of a recommendation. Now, the first successful candidate to treat HSDD, Addyi (flibanserin) (and pronounced add-ee) was approved this week by the agency for us in premenopausal women. Much of the media coverage of the approval employed an unfortunate shortcut to describe it – using terms to equate it with male treatments for erectile dysfunction – when it is in fact, quite different. In its press release, FDA stressed that the drug was coming with a Boxed Warning due to its potential effects when used with alcohol (fainting and low blood pressure) and that it would be available as a result only through certified prescribers. The REMS program also extends to pharmacies as well. The treatment, which is not hormonal, was also described by the agency has having a mechanism of action that is not known. The manufacturer – Sprout Pharmaceuticals – said in its press release that it was aiming to have the drug available in mid-October. It was a big news week here as it was also announced that the company was being acquired.
- Consent Decree Related to Supplement Manufacturer – Many times people are under the impression that FDA does not really regulate supplements so it is therefore worth noting when action is taken that sheds a spotlight on the role that FDA has in that regard. In April 2014, FDA issued a Warning Letter to Iowa Select Herbs regarding the misbranding of supplements due to the claims being made in relation to their marketing which would cause them to be drugs rather than supplements. Specifically the claims that FDA centered on related to stated that a range of specific products could treat and prevent very specific conditions. The letter provides a strong example of how FDA can act when certain conditions are present. This week the agency announced that a consent decree which will address the labeling issue.
That’s it for the week, and the summer. Enjoy the last lazy days before the return to school!
The summer is flying by. The lightning bugs have lit up and lit out. The grass has had it. Vacations are nearing an end. The last of the picnics are being planned. Somewhere someone is busy tuning up the yellow school buses so that in a few weeks time, they will be hauling the kids – some eager, some not – back to their school days. Heck, it won’t even be that long before we are looking at a snow day.
It was kind of a slow week (other than the OPDP Warning Letter re the Kim Kardashian social media promotion), here is a bit of what happened in the past few days:
- Big Court Decision on Off Label Speech – It was big news – bigger even than the Warning Letter from OPDP that was issued this week. Everyone by now will have heard the news by now that there was a court decision in New York this week that may put FDA on a bit of a leash when it comes to having its way on off-label promotion by a pharmaceutical company. Specifically Amarin Pharmaceuticals brought suit against the agency asserting that if information about a product were truthful and not misleading, then speech about an off label use should be considered a legal exercise of speech. How this will play out is still a bit up in the air and FDA could appeal, though the company said in a press release that it would begin promotional efforts consistent with the court opinion. I almost wrote a posting on this, but there were greater minds doing a better job of it and you can read some of them here on the FDA Law Blog and here on In the Pipeline.
- Sculpture Protesting FDA Policy on Gay Blood Donation – For many years FDA had a policy that virtually banned blood donations from men who have had sex with men. In 2015, the agency put out a new proposed guideline for blood donation from gay men proposing that blood be accepted from any gay man who has been celibate for a period of one year. While many feel the step is in the right direction, it nevertheless holds gay individuals to a different standard in spite of the fact that donated blood is screened. This week, media reports carried news regarding a new exhibit being put on at the American University Museum in Washington, D.C. featuring a sculpture that contains blood donations from various gay, bisexual and transgendered individuals encased in resin.
- FDA Responds to Energy and Commerce Letter Re Warning Letters - Back in a June posting in the Weekly Roundup, it was noted that FDA had received a letter from the House Energy and Commerce Committee seeking information on how the agency posts Warning Letters as well as how it decides whether to send a Warning or Untitled Letter. In late July, FDA responded to the letter and it has posted to the House E&C site. The deets are more than we can go into here in the Roundup, but I thought they were interesting. See what you think as well.
That’s it for me this week. As we wind down the summer, enjoy!