No postings this week – sorry about that – travel and business, but will shoot for some good ones next week.
This was another week of tropical rain – the kind that comes and dumps steady water as if a large sponge were being wrung out overhead. The garden is having a mixed experience – the lettuce has had it and so has the dill. The basil, rosemary and thyme on the other hand, appear thrilled. I am less so. In a few days, we will have the longest day of the year. In the meantime, it was an interesting week where the agency really made some headlines with some news that was both wide and deep and some interesting developments transpired.
- FDA Moves to Remove Trans Fats – By now, nearly everyone has heard the news that the agency announced this week related to Trans Fats. FDA is giving food manufacturers three years to remove all partially hydrogenated oils (PHOs) – the source of trans fats – from food. This action finalizes a 2013 preliminary determination that PHOs would no longer hold the Generally Regarded as Safe (GRAS) status. You can learn more about GRAS status here. While providing a three year window, FDA is encouraging consumers to check labels to reduce dietary exposure to PHOs. The agency noted in its press release that “currently” food that is labeled as zero transfat may in fact have up to .5 grams per serving. One wonders if the use of the word “currently” signals a change in the future.
- FDA Partners with PatientsLikeMe – PatientsLikeMe announced this week that the company had entered into a collaborative research agreement with FDA to assess how patient-reported data can have a role in risk assessment and risk management. This new effort appears to open up a new avenue for the reporting of adverse event experiences and pave a new way for the inclusion of patient generated data. In the larger context, patient generated data is occupying a bigger role in medical research – particularly with the addition of wearable devices. There was no word in the release from PatientsLikeMe on the details of the effort.
- FDA Takes Action on Illegal Website Sales – This week the agency announced that it was participating in the eighth sweep of action against websites globally that are selling unapproved or counterfeit drugs and devices to consumers. According to the release, action was taken against a total of 1050 websites. Called “Operation Pangea VIII”, FDA said it sent Warning Letters to operators of nearly 400 websites and in collaboration with other federal agencies did screenings and seizures of material through International Mail Facilities in various cities in the U.S. FDA also provides in the release resources to help consumers identify whether or not a source is possibly an illegal pharmacy.
That’s it for me this week folks. Have a good weekend and enjoy the longest day of the year. Happy Summer!
It is as if the calendar just knows when to turn up the heat. We have crossed over into the second week of June and already we face days that head into the 90s and late afternoon thunderstorms that characterize this time of year. It seems like only yesterday the daffodils were waving in a nippy Spring breeze. Soon, the newly arrived grass will look thirsty and sad. But let’s not get ahead of ourselves.
Some things did move ahead this week though – certainly there was a lot of advisory committee action, so let’s take a look at it.
- Cholesterol Considerations – The Endocrinologic and Metabolic Drugs Advisory Committee met on June 9 and 10 this week and both days reviewed data for two investigative compounds seeking a cholesterol lowering indication. On June 9, the committee reviewed Praluent (alirocumab) Injection – a monoclonal antibody. The sponsors, Regeneron and Sanofi announced that the committee voted 13-3 that the cholesterol lowering benefit of the compound exceeded risks to the degree that supported approval. The safety and efficacy data included more than 5,000 patients from 10 pivotal phase 3 double blind trials. On the 10th, Amgen got its turn to discuss data on another biologic for the proposed indication of cholesterol treatment called Repatha (evolocumab). According to media coverage, the committee indicated approval with an 11-4 vote, but also got a recommendation for approval in treating a rare subset of familial hypercholesterolemia caused by genetic disease in a unanimous vote.
- Asthma Treatment Recommendation – The Pulmonary-Allergy Drugs Advisory Committee also met this week on June 11 to consider another biologic, mepolizumab – an IL-5 monoclonal antibody, this time proposed to treat asthma as an add-on maintenance treatment in patients 12 and older, submitted by GlaxoSmithKline. The company announced a unanimous vote in favor of recommending approval (14-0) for use in adults, but ultimately did not recommend approval for adolescents aged 12-17 with severe asthma, seeking further data. The company mentioned that the PDUFA date for the compound is November 4. While regulatory filings have been made outside the U.S., it is not yet approved in any country.
- FDA Issues Guidance on Drug Development for Duchenne – The agency is also announcing the availability of a draft guidance for drug development to treat Duchenne Muscular Dystrophy (DMD) – a form of muscular dystrophy that is caused by a genetic mutation that leads to muscle degeneration and resulting decreased life expectancy and a condition where treatments are needed. A docket has been opened for the submission of comments.
That’s all for me this week. Stay cool everyone!
It has been a week of rain and gloom in our nation’s seat of government. It has been cold, gray and unpleasant. Commutes are nasty. The lack of sunshine is getting serious. But on the bright side, pollen has been washed away, the garden appears happy and baby birds have hatched in one of the hanging baskets of flowers I keep on the front porch. So the glass remains more than half full.
Here is a bit of what happened in FDA-world and a little beyond this week that I thought noteworthy and hope you do too:
- NIH Suspends Operations of its Clinical Center Pharmaceutical Development Section Following FDA Inspection – Big oops. On Thursday this week NIH announced that it had suspended operations of its own Pharmaceutical Development Section (PDS) following an FDA inspection. According to the release, FDA responded to the receipt of a complaint and conducted an inspection in late may and discovered what NIH termed as “serious manufacturing problems and a lack of compliance with standard operating procedures.” NIH Director Francis S. Collins, M.D., Ph.D was quoted as saying that he would be personally overseeing the steps to address the situation. The inspection report is located here and media coverage here.
- Congressman Concerned Over FDA Inspection Letters - And speaking of FDA inspections, Ed Silverman this week reported on the Wall Street Journal Pharmalot site an interesting development. Congressman Tim Murphy has sent a letter to FDA seeking details related to the agency’s policies in posting untitled letters regarding manufacturing problems discovered in the facilities of companies making pharmaceuticals. Specifically, he is looking for insights on the timing of posting such letters along with what does into the decision into how detailed the letters are when posted. The concerns seem to be related not to warning and untitled letters from the Office of Prescription Drug Promotion, but rather those that are results of inspections of facilities. The letter was sent ont he 27th of May – no word as to when FDA will respond or if the response will be posted.
- AdComm Approval for HSDD Drug – There have been past attempts to provide a treatment for women experiencing Hypoactive Sexual Desire Disorder but this week we saw the first to get a recommendation for approval by an FDA Advisory Committee. Sprout Pharmaceuticals announced that the company’s investigational product ADDYI (flibanserin) was recommended for approval in an 18-6 vote on the condition that certain risk management options beyond labeling are put into place. While men have had many pharmaceutical options for the treatment of erectile dysfunction, relief for women has not been as forthcoming. All eyes now go to FDA to see what it will do in response to the recommendation.
That’s it for me this week. Have a great weekend everyone.