Weekly Roundup 10.2.15

Joaquin is a knock knock knockin’ at our door. While the government did not shut down due to a political crisis, it may not be clear that a weather crisis won’t do the job. Washington can always use a good airing out, but a hurricane is actually not the preferred method. I hope it is dry and warm wherever you are.

My travel schedule this past week kept postings at a minimum, but here is the Weekly Roundup with a bit of what happened this week and a little bit from last, that was of interest:

  • Two New Diabetes Treatments Approved - Last Friday FDA announced the approval of two new diabetes medications – Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar control in adults with daibetes mellitus. Tresiba is a long-acting insulin and Ryzodeg 70/30, a mixture of a long acting insulin analog with a rapid acting one. The new treatments are manufactured by Novo Nordisk. The company press release with fuller information on Tresiba can be found here.
  • New Laser-Based Hearing Aid - FDA cleared for marketing a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound for people with hearing impairment. The device has two parts – a tympanic membrane transducer (TMT) which is placed into the ear canal on the eardrum through non-surgical means and a behind the ear (BTE) audio processor that sits on the outer ear but is connected to an ear tip that is placed in the ear canal. The release describes how the device works as follows – external sound waves received by the BTE processor are converted to electronic signals, digitally processed, amplified and sent to the ear tip, which contains a laser diode and are then converted to pulses of light. These then shine onto a photodetector in the TMT, converting it back into electronic signals, transmitting sound vibrations directly to the eardrum by direct contact. If that sounds a bit much, you can see more on the company website.
  • WHO Announces Change to HIV Recommendations - As someone whose career began in the earliest days of the HIV/AIDS epidemic when there were no effective treatments, it was absolutely breathtaking yesterday to see that the World Health Organization had issued a call for the wide scale treatment of all people with HIV and to offer treatment as a preventive measure for people at high risk. Because treatment has been shown to act as a preventive, with these new guidelines WHO states that they are seeking to end the epidemic as we know it by 2030. The recommendations mean an expansion of the number of people receiving treatment from 28 million world wide to 37 million.

That’s it for me this week folks. While I didn’t get to posting due to travel, I have some in the can and ready to go next week when we will look at the pain category and regulatory enforcement, among other things. Have a good weekend and if you are on the East Coast, let’s hope the rain and wind is not too bad.

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FDA Adds a New AdComm for Patients

This week FDA published a Federal Register announcement stating that the agency was establishing a new Patient Engagement Advisory Committee designed to provide counsel to the Commissioner on issues related to medical devices. The agency said that the scope is meant to include guidance and policies, clinical trial design and patient preference related to host of issues. FDA also stated that the committee would be put to work identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequence that could result from FDA policy.

Some specific things FDA says that it is considering asking from this committee include identifying the points, and presumably the process, for patients to provide input during the life cycle of a medical product – from pre-approval to post-approval, and also determining that the priorities and focus should be for such input.

There will be nine voting members of the committee who have backgrounds or expertise in clinical research, primary care and in general of health care needs and trends.  The committee will operate like other advisory committees, with staggered terms and may have non-voting members such as an Industry Representative.

This is the second step FDA has made that institutes some changes in the medical device world Earlier in the month, the agency announced the release of information through OpenFDA. In a September 3 blog posting on FDA Voice the agency stated that they were making already public information on medical device adverse events and recalls more readily available through FDA’s Application Programming Interface to expand access to the data.

The establishment of such a committee will likely be viewed as a good thing by patient advocates.  FDA also published a notice for individuals and organizations potentially interested in serving on the committee.

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Weekly Roundup 9.18.15

For those of us hungry for it, we had our first taste of autumn. It has been lovely to sleep with windows open. Granted the long shadows appear earlier than they used to and the sun is setting from a new angle. The Farmer’s Markets are selling off the tomatoes and corn and the root vegetables are beginning to appear in greater number. Summer storms have stopped and the leaves will soon grow tired.

But we won’t. Here is a bit of what happened this week:

  • New FDA Commish On the Way? – To the surprise of no one, the White House announced a slew of new appointments this week and among them was the name of the newly proposed FDA Commissioner Dr. Rob Califf. Since March 2015, Dr. Califf has been the Deputy Commissioner for Medical Products and Tobacco at FDA and has came to the agency from the Duke University School of Medicine and the Duke University Medical Center. And he is a former advisory committee member, having served on the FDA Cardiovascular and Renal Drugs Advisory Committee from 1996 until 2000. He has many other accolades, achievements and qualifications for the job which you can read here. The appointment gets him part of the way there, the next hurdle will be confirmation by the Senate.
  • FDA Blocks Sale of New Ciggies - The agency announced this week that it had issued orders to block the further sale and distribution of four brands of cigarettes being marketed by R.J. Reynolds Tobacco Company. According to the FDA release, the four products entered the market under a provisional period where the company had to submit an application outlining substantial equivalence of the product to an existing, valid “predicate” product. In examining the applications, the agency found differences existed between the products and their predicates that made them not substantially equivalent and therefore issued the orders.
  • Fast Trackers and Breakthroughs - Two notable fast track status updates, both on the same day. Mapp Biopharma announced that the company had received fast track status from FDA for ZMapp™, an investigational compound being researched in relation to treating Ebola. Also Can-Fite Biopharma announced fast track status had been granted to CF-102 being studied as second-line treatment of hepatocellular carcinoma (HCC). Both drugs had already received orphan designation. Additionally this week breakthrough therapy status was given to BMS’ Opdivo being considered for the potential indication of treating advanced or metastatic renal cell carcinoma (RCC). Need a brush up on the different status designations of Fast Track, Breakthrough, Priority Review and Accelerated Approval?  Then click here.
  • New Approval in Schizophrenia and Bipolar – Vraylar™ (cariprazine) capsules received FDA approval this week in the treatment of schizophrenia and bipolar disorder in adults, the agency announced. As with all other FDA-approved drugs to treat these conditions the label will carry a Boxed Warning. The company press release can be found here.

That’s it for me this week folks. Have a wonderful weekend.

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Then and Now – Shutdown Showdown

The last time we faced a government shut down, there were some advance communications on how various government agencies were going to be operating during the “event”. Last time, the executive brand had issued a memorandum on September 17, this time there seems to be less information about what may happen or what may not. Perhaps we are still too far out from the time or perhaps we are just getting used to it.
But in any case, it seemed like it might be a good idea to begin thinking about some of the things. What did FDA do last time?

Here are a few things to note:

  • Back in 2013 (and even in 2011), the answers ahead of time were not so black and white. There was a lot of gray area. Prepare for the same this time, even based on past experience.
  • FDA had to furlough thousands of employees and had a page set up to answer employee questions. Presumably that information will be similar for this time.
  • There was some thinking last time that while the government had indicated that only essential operations would continue during the shutdown, that some FDA activities funded by user fees might occur – such as advisory committees. It should be noted, however, that some advisory committees were postponed due to the shutdown. As of right now, there is only 1 Advisory Committee meeting and it is not scheduled until October 23 (last time there were nine meetings scheduled for October – leading one to wonder if schedulers are on to something).
  • A question raised last time was whether or not approvals and PDUFA dates would be affected - but there are press releases announcing approvals in the files that were released during that time and the media office was staffed by an individual and the agency did note that where carryover user fee funds were not available during the shutdown, that existing dates would be extended by the number of days of the shutdown.
  • Food and drug inspections might not carry forward during a shutdown.

Anyone interested on catching up on what the impact was of the last shutdown can find some reading here “Impacts and Costs of the October 2013 Government Shutdown”. Among the FDA related impacts were:

  • 500 delayed food and feed domestic inspections and 355 safety inspections under state contracts
  • delay in the approval of drugs and devices – noting in particular an inability of FDA to accept applications for approval
  • inability of FDA to answer consumer questions about regulated products

Hopefully the lack of advance word is indicative of a non-event.

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Weekly Roundup 9.11.15

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.

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