I bring you the Weekly Roundup today from Cape Cod where there is a lovely sense of autumn in the air, but blue skies and lovely shoreline allowing us to still remember the summer’s most pleasant days.
And here is what happened this week in reality-based Washington, D.C.
- Ebola Candidate Treatment Emergency Use - Reuters reported this week that FDA was allowing the emergency use of Tekmira’s investigative compound TKM-Ebola being studied as a treatment for Ebola. Canada also issued a similar authorization. And the company announced this week that it would be joining an international consortium to conduct clinical trials for new treatments in West Africa.
- FDA Warns Purveyors of Ebola Treatments – On a related but entirely different note, FDA issued warning letters to 3 companies that the agency said were marketing preventions and/or cures for Ebola. The letters were issued on September 22 and 23 and represented a range of types of products. FDA has put up a web page on Ebola and overviews distinctions between investigative compounds and fraudulent products.
- CyberSecurity and Medical Devices – FDA announced a public workshop for October 21 and 22 to be held in Arlington, Virginia entitled “Collaborative Approaches for Medical Device and Healthcare Cybersecurity” and the purpose of the meeting is to identify barriers to promoting cooperation and to consider strategies to overcome various challenges.
- Social Media Guidance Comment Period Extended - FDA announced that it would be extending the time period for comment from the public regarding the two social media guidances issued in June. The agency took five years to produce the guidances and is seeing fit to give the public a bit more time to provide input. According to the notice sent by FDA, the time period will be extended from September 29 to October 29.
That’s it for me. Back to vacation. Have a good weekend everyone.
The Sunshine Act will peek out from behind some, but not all, of the clouds on the horizon soon, leading to a new day in transparency on payments between the medical products industry and those who provide care. Data will be published by HHS on payments made to key stakeholders including physicians and teaching hospitals among others. Much has been written and much will be written. My own humble contribution has taken place from time to time looking at the issue here in this country and in France; looking at how the release of CMS data this Spring was covered by media as a proxy for what we might see on Sunshine coverage; and a Webinar that was held in June providing tips for preparing for the publication of the data from a communications point of view.
The time is near. For those who have procrastinated, here from the Webinar are a few of those observations and tips.
- The first wave of coverage will likely focus on the payments – how much went to where – with comparisons and rankings, the second wave may then focus on how well the implementation of the law is working, or not (reporting errors, e.g.);
- Focus may well be on which doctors received high levels of funding, which institutions and which companies paid the most, which parts of the medical profession received the most funding – and these stories will likely be on a national and regional/local level;
- Because of the connection with money – the skew is likely to be negative;
- Stakeholders will include teaching hospitals, non-teaching hospitals, physicians, research centers, medical societies, CMS and of course, patients.
- Messaging will be important for individual stakeholders, not just trade associations and groups and is best developed ahead of time and that takes into consideration not just what stakeholders feel a need to say, but what they think audiences – particularly patients – may want to hear;
- Understand ahead of time your stake – what are the characteristics and scope of your involvement – what is your individual story and assess strengths and vulnerabilities;
- Also understand that this is an opportunity to educate people about the relationships that exist so provide a comprehensive picture – don’t just respond to individual snippets of the story or the data – which will appear defensive;
- That said, be able to define the individual elements of those relationships – help media/people understand what the benefits are to scientific advisory boards, clinical trials, etc.
- Make sure internal stakeholders help devise messages to provide the most accurate messaging;
- Have materials ready – FAQ, Talk Points and Backgrounders to help convey the messaging.
With the potential holding back of some of the data, the resulting story may be even more confused than it would have otherwise been and may complicate the ability of media to cover the story of the data publication considerably. Good preparation will help mitigate some of that circumstance, particularly in messaging, that will allow individual stakeholders to help shape their story, rather than have the story shaped for them.
Argh! It is International Talk Like a Pirate Day! Fear not Matey! I’m not gonna write my whole posting in pirate-speak, though it be a tempting morsel to ponder.
There were lots of approvals this week and finally a wee bit of action from the Office of Prescription Drug Promotion (OPDP) which so far this year has produced very little output in the way of warning or untitled letters. The one sent out this month brings us to a grand total of 7 for the year, far below any rate of production recorded on these humble pages.
- New Type 2 Diabetes Drug Approved - FDA gave Lilly’s Trulicity (dulaglutide) a green light this week. Trulicity is a once-weekly subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with Type 2 diabetes. The drug is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels and comes with a Boxed Warning regarding an increased risk for thyroid C-cell tumors based on studies in rats. FDA will be looking for some post-marketing studies for the compound – studies in pediatric patients on efficacy and safety as well as others. According to the company release, Lilly plans to make Trulicity available in single dose pens in two doses.
- Treatment for Opioid-Induced Constipation Approved – A common side effect faced by patients using opioids to control pain is constipation as the drugs reduce the motility of the gastrointestinal tract. This week the agency approved a new oral treatment for opioid-induced constipation in adults with chronic non-cancer pain. According to FDA’s release, the results of the trials measured two doses – 25 mg and 12.5 mg – and found that 44 percent of study participants at the first dose and 41` percent at the second dose experienced an increase in bowel movements compared to 29 percent who were on placebo. The agency is looking for a postmarketing study related to cardiovascular adverse events. The company said it expects to have the drug available to patients during the first half of 2015.
- AdComm Vote on Testosterone Replacement Therapy Candidate – A joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee met this week to consider approval of Testosterone Undecanoate – brand name REXTORO, put forward for consideration by Clarus Therapeutics. The committee against the overall risk/benefit ratio by a large margin. As is well-known, FDA is not required to follow the recommendation of the advisory committee.
That’s it for me today, matey. To celebrate the day, I’ll be having a nice seafood lunch! Argh!