Mark S. Senak's Blog, page 48

Tracking Legislation

Last week I posted some of the latest legislative proposals out of the 113th Congress that would affect either some aspect of the pharma industry or FDA.  That information is housed on a tab on the Eye on FDA site about proposed legislation.

But if you are interested in tracking legislation yourself – especially particular bills, there are a number of handy tools to help you out.  Below are some that I have found useful from time to time and each offer some unique characteristics and services that may fill a particular need you have beyond tracking.

Congress.gov – This site is a government sponsored site that is still in beta, but that is far more user-friendly than previous government sponsored sites that tracked legislation. Here on the landing page, you can have access to search for particular bills using either the bill number or a key search term, a link to the Congressional Record, ability to search for a particular member and to see the delegation from a particular state as well as a link to an explanation of the legislative process.  When you search for a particular bill number, you will get that number in the current Congress as well as in past sessions.  The result is similar when you use a search term (such as “pharmaceutical”), but there are a number of filters that allow you to narrow your search (to the current Congress, for example).

GovTrack.us – This tool is brought to you by a private company called Civic Impulse, LLC. From the landing page of this site, you can not only look up proposed legislation as well as members, there is also a link to research voting records.  The site has the added benefit of giving you the ability to search the 50 states as well for legislation using a key word search and has a Twitter feed @GovTrack so that you can follow commentary and developments.

OpenCongress –  While Congress.gov is a government resource, and GovTrack sponsored by a private company, OpenCongress comes to us from the non-profit sector – a project of the Participatory Politics Foundation and the Sunlight Foundation.  Like the other two, there is the ability to search for bills based on number and key words and like GovTrack, from the landing page you can jump to voting records.  Two nice features about OpenCongress, among many, are the fact that you can do head-to-head voting comparisons of members and there is a page from the landing page that you can jump to that allows one to write a letter to your member of Congress.  A section called “The Money Trail” also allows one to see – by industry sector – where contributions have gone.

Happy hunting!

Proposed Legislation in the 113th Congress

During the course of the 112th Congress, there was a good deal of legislation introduced that, if passed, would impact either the pharmaceutical industry or FDA itself.  Much of that legislation did not pass but some of it has found a new home in the ranks of proposed legislation in the 113th Congress – and some of it is looking strikingly similar.

Below is a partial listing of proposed bills that would affect either the way FDA or industry does business.  Some of the bills focus on issues of abuse of opioids, increased access to prescription drugs, costs or even the marketing of drugs (with a proposal to cut the business deduction for DTC).

As new bills affecting FDA or industry are introduced, they will be included on this list which is housed on a tab entitled “Proposed Federal Legislation – 113th Congress” located on the main Eye on FDA landing page.  (Also on the tab are some resources to help you track current proposed legislation and research past efforts.)

House

H.R.413-To eliminate the 2-year delay in including oral-only ESRD-related drugs in the Medicare ESRD prospective payment system, as provided under section 632(b)(1) of the American Taxpayer Relief Act of 2012.

- Link to Sponsor Peter Welch Release on the Bill.
H.R.460 - Patients’ Access to Treatments Act of 2013 – Establishes cost-sharing limits for health plans that cover prescription drugs and use a formulary or other tiered cost-sharing structure.
H.R.486 - Stop Tampering of Prescription Pills Act of 2013 – Requires FDA to prescribe new drug application requirements for abuse-deterrent drugs that (1) contain an opiate, (2) are oral, (3) have properties that lend themselves to abuse/misuse, and (4) contain one or more additional ingredients intended to deter abuse through pharmacological effects.
H.R.672 - Prescription Drug Abuse Prevention and Treatment Act of 2013 - Provides for award grants to states and non-profits for consumer education about opiod abuse, including methadone abuse and puts into place new training requirements for practitioners.
H.R.923 - Say No to Drug Ads Act – This would eliminate any tax deduction for the cost of direct-to-consumer advertisting for prescription drugs.
H.R.928 -Medicare Prescription Drug Savings and Choice Act of 2013 -  Aims to lower prescription drug prices through directing HHS to negotiate prices with industry, to establish a formulary and to encourage the use of a formulary and formulary practices.
H.R.1024 - Medication Therapy Management Empowerment Act of 2013 -Amends Part D to provide access to services under medication therapy management programs for Part D eligible individuals with a single chronic disease.

Senate

S.77 - Prescription Drug and Health Improvement Act of 2013 – Repeals prohibition against interference by HHS Secretary with negotiations between drug manufacturers and pharmacies and prescription drug plan sponsors, and requires a particular formulary or instituting price structure for the reimbursement of covered part D drugs.
S.117 - Medicare Prescription Drug Price Negotiation Act of 2013 – This bill would direct the HHS Secretary to negotiate prices for drugs under the Medicare Part D Prescription Drug Program.
S.214 - Preserve Access to Affordable Generics Act - Would permit the FTC to initiate a proceeding against parties to any agreement that resolves or settles a patent infringement claim in connection with the sale of a drug.
S.348 - Prescription Drug Abuse Prevention Act of 2013 - Puts into place training requirements for prescribers of methadone or other opioids and to require each registered opioid treatment clinic to make arrangements for each patient who is restricted from having a take-home dose to receive a dose under supervision when the clinic is closed. (Related to H.R.672)
S.408 - Medicare Prescription Drug Savings and Choice Act – Related to H.R.928.

Warning and NOV Summary – 4th Quarter 2012

To gain insight into the most recent thinking at FDA’s Office of Prescription Drug Promotion (OPDP), Eye on FDA regularly reviews the number of letters and types of violations that were cited by the agency each quarter in Warning Letters and Notice of Violation (NOV) – also known as Untitled Letters.  I usually aim to get these out about 4 weeks after the end of the quarter, but here it is – a bit late.

This quarter there were a total of six letters issued, for a  grand total for 2012 of 28 letters, two fewer than last year.

For this quarter, the 6 letters carried a total of 15 different violations involving 9 different communications vehicles.  There were NO warning letters issued, 6 letters were Notice of Violation (NOV) or Untitled letters.   Of the 9 communications vehicles, 5 were digital while the balance were non-digital.  These included 2 visual aids, 1 sales aid, 4 involving Website copy, 1 video and 1 pitch letter.  Here is a breakdown of the violations incurred:

As usual the most common violation was the omission or minimization of risk.  It is also, however, noteworthy that there were two violations for the relatively less common promotion of an unapproved drug.

Every so often, OPDP carves out “new territory” with its regulatory action letters.  It is, after all, one of the few means by which FDA/OPDP enunciates policy – the other being through the painstakingly slow and laborious process of developing draft guidances.  For example, in 2009, the agency issued a slew of letters that cited a common and long-standing practice to use sponsored links in the context of product promotion.

The last quarter of 2012 involved an instance where another common practice – using a pitch letter to transmit a press release – was defined as part of material that is considered promotional. Therefore the fact that the pitch letter contained information about the product that included the indication and efficacy claims but did not include risk information within the letter (only within the press release) was deemed a risk violation.  That means one of two things for communicators.  Either do not mention information about a drug’s in a the text of the transmittal letter for a press release, or if you do, include risk information and run it through MedReg.

As for the first quarter of 2013, sequester at FDA may have kicked in a little early. So far there have been only two letters issued (none in January).

Job Hunting? – Social Media Career Resources in Pharma

As I mentioned last week, I have put together a data base – a constant work in progress – of pharma activities in social media.

One of the fields on which I can perform sort on is one where I have assigned each social media effort with a classification of its functional purpose.  So, I can sort to see which of the social media assets are product-based, which are disease-specific, which are corporate. One of the assigned categories is Career.

To that end, I thought it might be handy to provide potential job seekers with an overview of what kinds of social media career resources that have been provided by industry.

There are bound to be some missing here, so please email me with any pharma-sponsored resources that should be added.

Here are the ones I know of:

Facebook -

Abbott Careers
AbbVie Careers
AstraZeneca Careers
Medtronic Careers
Merck Careers
Novo Nordisk Graduate Programs

Twitter – While there appear to be a fair number of these, it should be noted that some of the feeds have not had entries in several months, some have sporadic entries, and still others are quite active.  Also if you care to follow just pharma career twitter feeds, a Pharma Jobs twitter list is available on the Eye on FDA Twitter feed.

AmgenCareers
AstraZenecaJobs
JoinAstraZeneca
BayerKarriere (Germany)
BoehringerNordics (Scandanavia)
Endopharmajobs
GenzymeJobs
GenzymeCareers
JNJCareers
MedDeviceRecruiter
MediCareers
MedtronicJobs
MerckCareers
MerckJobs
NVSOncoCareers
Pfizer Kariyer (Turkey)
RocheCareers (Switzerland)
RocheJobsUSA (US)
GenentechJobs
SanofiKarriere (Germany)

Two other resources that may be useful, but are not pharma sponsored are

Pi nterest

AstraZeneca Careers – This is a global board.
Roche Careers – This board comes out of Basel.

YouTube

AstraZeneca Careers

Good hunting!

Offshore Tweets and Pharma

A Database of Pharma and Social Media!

I have lately had a hankering to be putting together more data bases that let me see more of what is going on in the world.  I like databases.  I like asking questions and getting answers.  Data bases are, I think, like looking in a microscope.  You see something very differently when you look at it up close than you can from far away.

One of the databases I have been working on is one that will be an on-going work in progress that focuses on the activities of pharma and social media.  Accordingly I have entered into a data base every pharma Twitter feed, Facebook page, YouTube channel and Pintrest page of which I am aware.  I have not yet entered into it every blog or Google+ page.  But so far, I have identified over 200 pharma Twitter feeds, over 150 pharma sponsored or funded YouTube channels, and over 100 Facebook pages.

The fields that I am tracking in the data base include a number of characteristics – what type of page is it – corporate, product, disease/conditions specific (and if so, what disease?) and things like that.  This can be very handy for assessing the social media landscape in a variety of ways.  And one of the fields tracked for the Twitter feeds is the country of origin for the feed – which gets me to my point – but in a minute.

On my own Eye on FDA twitter feed, one thing that I have noticed when looking at my statistics is that (1) there have been some growth spurts in the number of my followers lately, and (2) that much of the growth seems to be happening from outside the U.S.  I know this because I have watched the country of origin profile of followers who end up clicking on a link in one of my tweets and noticed that the proportionate number of those from the U.S. has been shrinking over time.  While it used to be that around three-fourths of my clickers were U.S., it is now just over half.

As state above, I have identified over 200 pharma Twitter feeds and I assumed that most of them would be U.S.-based.  On doing a sort on country-of-origin, however, I found that while the U.S. had a plurality of the feeds (89), it did not have the majority of feeds.  The country with the second largest number of pharma-sponsored Twitter feeds was Germany (20).

Even though the database is probably lacking many existing social media efforts, there are enough to give me a good lay of the land.

Another of the fields being tracked is the number of followers each feed has – a time consuming field as it changes and needs to be updated to be accurate.  The last numbers were tracked in the summer of 2012, but reveal that of the five largest pharma/device sponsored Twitter feeds, only the top two are U.S. based, followed by one in Korea, one in Switzerland and one in the U.K.

And so, you see, this is why I like data bases.  They open my eyes and challenge my suppositions with real data….and I did not realize that pharma and tweets were so much a foreign affair.

Upcoming AdComm Topics

Earlier this month, I put up the schedule for the dates that FDA has scheduled for advisory committees for the year to give some limited as it provides a little insight into what can be expected in the way of approvals, though this year there were so many dates “TBD” that it may be a slightly more uncertain exercise than in years gone by.

In 2012, FDA approved 39 new drugs – the most in 16 years.  For this year, there are already a large number of meetings scheduled to consider new NDAs as well as some policy matters.  Here is an overview of what is to come for the rest of the first quarter 2013:

January 29-30 – Pulmonary-Allergy Drugs Advisory Committee - On the 29th, meeting to discuss NDA for olodaterol (proposed name Striverdi Respimat) for proposed indication to treat COPD, sponsor Boehringer-Ingelheim.  On the 30th, the committee will meet to discuss NDA for mannitol inhalation powder (proposed name BRONCHITOL) for the management of cystic fibrosis.
February 12 – Risk Communications Advisory Committee - The committee will meet to discuss a very interesting topic – general factors in risk communication about FDA approved products, including approaches to avoid message fatigue and related communications barriers such as prevention or warning fatigue or inaccurate risk perception.
February 12 – Blood Products Advisory Committee – Meeting at Fishers Lane, this Blood Products AdComm will meet to discuss a BLA for proposed indication as a botulism antitoxin heptavalent (A, B, C, D, E, F) -(Equine), sponsor Cangene, seeking licensure under FDA’s authority to approve a product based on evidence of safety in humans and efficacy in animals when human efficacy studies are not feasible or ethical.
February 14 – Medical Imaging Drugs Advisory Committee – This meeting will be to consider NDA for gadoterate meglumine injection (proposed tradename DOTAREM), sponsor Guerbet, LLC, proposed for use as MRI in the brain and spine to detect areas with disruption of the blood brain barrier and/or abnormal vascularity.
February 22 – Neurological Devices Panel of the Medical Devices Advisory Committee – This committee will meet on the 22nd to discuss, make recommendations and vote on information regarding the premarket approval application (PMA) for the NeuroPace RNS System proposed as adjunctive therapy in reducing frequency of seizures in adults with partial onset of seizures from no more than two foci that are refractory to two or more anti-epileptic medications.
March 4 – Reproductive Health Drugs Advisory Committee – The committee will meet to discuss 2 NDAs in one day – the first being for Depomed’s gabapentin 600 milligram tablets for the proposed indication for the treatment of moderate to severe vasomotor symptoms due to menopause; the second slated for the afternoon discussion will be to consider Noven Therapeutics’ NDA for paroxetine meylate 7.5 mg capsules also for the proposed indication of treatment of moderate to severe vasomotor symptoms due to menopause.
March 5 – Joint Meeting of the Reproductive Drugs Advisory Committee with the Drug Safety and Risk Management Advisory Committee – The Committees will meet jointly to discuss whether the benefit of cacitronin salmon for the treatment of postmenopausal osteoporosis outweighs any risk.
March 7 – Pulmonary-Allergy Drugs Advisory Committee – This meeting will be to consider another proposed COPD treatment.   Submitted by GlaxoSmithKline, the NDA for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREAO ELLIPTA) seeks approval for the treatment of airlfow obstruction and for reducing exacerbations in COPD patients.

Election Impact – The New Class

Around elections, I have usually tried to provide some insight into where candidates stood on health care related issues, particularly affecting the development and marketing of medical products.  I wasn’t able to do that through this election cycle, but now that the dust has settled, new members to Congress elected and sworn in, it is a good time to assess where we are.

Fortunately, friends over at TogoRun - a health care public affairs agency with offices here in Washington, New York and in London – produced a handy guide to the newly elected. THE FRESHMAN HEALTHBOOK is a downloadable handbook looks at the new members of the 113th Congress through a lens of positioning on key health care issues including the Patient Protection and Affordable Care Act (ACA), medical innovation, children’s health, and Medicare among other issues.  It is a concise yet comprehensive overview of the new members and their positions.

One can quickly see that this new class offers more diversity and breaks new ground in many ways.  Ironically, despite that increased diversity, it is also reported in the media that the prospects for this Congress be able to overcome some of the partisan obstacles of the past is not likely.  THE FRESHMAN HEALTHBOOK is a resource that helps you decide for yourself, as well as to get a lay of the land with respect to issues that are of importance to you.

FDA’s AdComm Schedule for 2013

Happy New Year everyone.

Usually by the end of the year, FDA publishes a tentative calendar for Advisory Committee meetings to be held for the upcoming year, however it appears that the calendar was just published today in the Federal Register and is reprinted below.

It is always interesting in what therapeutic areas the agency anticipates that it will be reviewing applications.  In past years, the agency provided more specific dates than was provided this year where there are a number left “TBD”.  However it appears that the committee with the most meetings will likely be the Oncologic Drugs Advisory Committee, consistent with years past on the CDER side, while on the CBER side Vaccines and the Celluar Tissue and Gene Therapies AdComms appear to have the most activity.  Naturally FDA cannot say with certainty at this point how many meetings or precisely in what areas advisory committees will be meeting, but this provides a little insight into what they are anticipating.

Here is how CBER and CDER stacked up:

Now What? Post-Election and FDA

We are finally post-election.  The sense of relief that one can watch or listen to broadcast television or radio without seeing campaign ads is still being felt nationwide.  Facebook sidebars are free of political jabber and de-friending over politics has diminished considerably.

One of the key points of debate in the election was, of course, health care reform – embraced even by the President as “Obamacare”.  Governor Romney made many statements about what he would do his first day in office, and among them setting about to repeal Obamacare.  One of the many realities to sink in now is that, after going to the Supreme Court and being found constitutional and having survived an election where repeal was promised, Obamacare is now the law of the land, and here to stay.  For healthcare broadly, that means a lot (and here is a handy overview on the entirety of the Act)- for FDA, the continued presence of the reform also has ramifications.

Naturally, the election has far reaching consequences for all stakeholders in health care – which by the way – is everyone.  Here are just a few of the many as it relates to FDA.

In fact, while the primary focus of the Affordable Care Act (ACA) was to provide coverage for the uninsured under a national plan, there are a number of ancillary provisions of the Act many of which affect FDA.  Given the milestone of the election, there is opportunity to review some of them, though I am likely to have missed many, and to provide some resources for tracking progress.

For monitoring a good part of what is happening, FDA has kindly provided a partial overview of what it is doing by setting up a page on its FDA Track system with a profile of its efforts on health care reform.  Here is an individual list of the tracks that have been set up:

Presentation of Prescription Drug Benefit and Risk Information
Improving Women’s Health
Removing Barriers and Improving Access to Wellness for Individuals with Disabilities
Nutrition Labeling of Standard Menu Items at Chain Restaurants
Approval Pathway for Biosimilar Biological Products
Minority Health
Labeling Changes

Of note, most of the delays noted in the dashboards have to do with the issuance of guidance documents.

Viewing Video’s Regulatory Profile

Happy Election Day.  Make sure you vote!

Are you considering putting together a video that contains a patient of physician testimonial?  If you are, you will want to take extra care in considering two things – how you present your risk information and how you script the video.

Looking back through 2005 at the regulatory action letters sent by FDA’s Office of Prescription Drug Promotion (OPDP) – formerly known as DDMAC – one can see that as a communications vehicle, videos have their own issues when it comes to staying within regulatory communications confines.

By my count, since 2005, there have been 235 letters issued by OPDP – covering both Warning Letters (WLs) and Notice of Violation (NOVs) letters citing around 315 different communications vehicles for over 600 violations, including among others, risk omission or minimization, superiority claims, overstatement of efficacy, unsubstantiated claims and broadening of indication.  Here is how those letters netted out proportionally among the various violations and you can see that risk minimization/omission is the biggest category (43%), followed somewhat distantly by overstatement of efficacy (21%) together comprising nearly two-thirds of all violations.

But when you look to video (excluding DTC ads), which are more likely to contain patient or physician testimonials, the proportions change.  There were by my count 15 letters from 2005-2012 (inclusive) citing 35 different violations among these categories, but over 80%, or 4 out of 5, involved risk minimization/omission or overstatement of efficacy.

Placement of risk information in videos has its challenges – putting it at the end like credits to a movie may not cut it.  And when people talk about their own experiences with a treatment, may include reference to outcomes that is not typical or supported by clinical data, making the scripting (and review of the visual representation), extremely important when producing a video.  It is not a bad idea to review all 15 instances of videos and letters to get a good idea of what the regulatory parameters are not only on content, but on presentation.

So in the end, extra care may need to go into putting together and evaluating a video that contains a testimonial before it is put out in the world for our viewing pleasure.