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Tag Archives: regulatory regime

Topic 44 – Amarin Settlement and What It Means for MA

We have been following the developments in the Amarin off-label communication case for awhile and you can find our posts that provide background here, here, and here.

In brief, Amarin has an FDA-approved indication to market its fish oil supplement as a treatment for very high triglycerides. It conducted a study that showed it lowered the triglycerides in moderately high patients but the FDA declined to approve the label extension because Amarin failed to prove a link to prevention of coronary artery disease. Amarin then informed the FDA that it intended to communicate the triglyceride lowering data to the market and the FDA informed them that it would consider any such communication off-label promotion. Amarin then sued the FDA for unfair restraint. Amarin was granted an injunction against the FDA, which appealed the decision.

In the latest development, the FDA has settled with Amarin, closing down the appeal before a ruling could be made to set clear precedence. In the settlement, which can read about here, the FDA agreed that Amarin could inform doctors of the studies supporting the fact that its product lowered triglycerides in a range of patients as long as the data presented was truthful.  It also set up an “optional” provision in which Amarin can meet bi-annually with the FDA to review the material that they wish to present to ensure that the FDA will find that information truthful and any disagreements from these discussions would be sent to a court to make the final decision.

The FDA’s perceived fear of a precedence setting ruling is not going to go unnoticed. Already another pharma company, Pacira, is suing the FDA under similar circumstances, which you can read about here.

If this case is also settled, expect to see the floodgates open.

It is more than past due time for the FDA to provide clear guidance to industry on the use of truthful, non-misleading communication of scientifically valid data that is not supported by the label. When that guidance is finally offered, it will be a game changer for MA. We believe that most organizations will realize that the safest way to communicate such scientific data will be through the use of peer-to-peer communication driven by medical science liaison-type roles and this will lead to a major expansion of many MSL groups.

We will continue to follow this story. We would love to know what you think. Leave a comment.


Topic 40: BREAKING: Court Rules FDA Cannot Prevent Truthful Off-label Promotion

In a court case that may have huge implications for pharma, a federal district judge in Manhattan ruled that the FDA cannot prevent a company from conducting off-label promotion if the promotion is truthful and scientifically accurate.

This ruling stems from the Amarin case that we discussed HERE.  In that case, Amarin argued that the precedent set by the Caronia case (which we discussed HERE) allowed them to promote off-label if the information shared was truthful and not misleading.  The FDA argued that the Caronia ruling was specific to those circumstances only and did not apply to Amarin.  Judge Engelmayer wrote in today’s ruling that “…A fair reading of that decision refutes the F.D.A.’s view that the Second Circuit’s ruling was limited to the facts of Caronia’s particular case.”

While this only currently applies to the circuit in question, it is a clear precedent that will need to be addressed if the FDA intends to retain its current regulatory approach to off-label promotion.  The FDA has not stated whether it intends to appeal but it did not appeal the Caronia ruling, a decision some pundits felt was made to avoid having a broader precedent set for allowing truthful off-label promotion.

This is an ongoing story but it could have some major implications for pharma and medical affairs.  Stay tuned to this space for more developments as they occur.

Any comments or thoughts on today’s news?  Click here to share them.

Topic 38 – FDA Comments on Off-label Dissemination – Did it just tip its hand on upcoming off-label policy?

Have you had the opportunity to follow the Amarin lawsuit against the FDA?  If not, a quick recap:

 Amarin is literally a fish-oil salesman – they have fish-oil pills that are already FDA approved for the treatment of very high levels of triglycerides.  They had conducted clinical trials to expand their label to patients with lower levels of high triglycerides.  The FDA rejected their application.  Amarin decided it wanted to share the results of those studies anyway since they were positive and sued the FDA for the right to share its data on off-label use.

The interesting part comes from the FDA response letter.  Putting aside their primary concern that Amarin failed to work with them before suing them, the letter signed by Janet Woodcock went on to layout the condition in which Amarin (or for that matter any pharam company) can share off-label data.

First, the letter reiterated what we already know and have discussed: the reprint exemption to off label communication – distribute reprints from peer-reviewed journals, avoid some simple issues like highlighting only the “good” passages, and you are in the clear.

But then the letter goes on to say that Amarin can also write up and distribute its own summary of the results of their trial if the write up:

  • Remains factual and does not omit material information or introduce bias
  • Includes full data for each treatment group
  • States that the current label does not approve of the use
  • States that the impact on the off-label use has not been determined
  • Shares data about other, known similar studies that may have different results
  • Any financial or affiliation biases between the firm and the people who conducted the study

They go on to add that to protect against being misleading the company should:

  • Provide a copy of the current Package Insert
  • Provide a copy of any relevant reprints
  • Discuss these topics in an educational or scientific setting and not as a part of a promotional discussion or attached to promotional materials
  • Discussions should be conducted by persons with the appropriate background or training to accurately communicate scientific information

While that is still a lot of hurdles, that is a long way from reprints only.  And while these are NOT an official policy now, I think this is telegraphing what we should expect to see in the upcoming policies.

I particularly like the final bullet point which makes it clear that these topics need to be discussed by roles that sound very much like MSLs.

To speculate, if the FDA were to allow establish this as the policy, it would surely free up MA to proactively share both off label and label supportive information.  That would be a big improvement for some MA organizations that deny all proactive sharing of off-label information.

You can find the letter HERE.  The juicy bits begin on page 8.

What do you think?  Click here to leave a comment.

Topic 34: New FDA Consumer Advertisement Guidance and Potential MA Impact

Have you seen the new FDA guidance about disclosing risk in consumer-directed print advertising that came out in February? (You can see it here) Unless you are a gluten for FDA guidance-reading punishment, my guess is that you skipped this one since it seems to be commercially focused.

BUT, there is actually something that MA should be aware of and perhaps an opportunity to add some value to our commercial brethren. The focus of the guidance is straight forward – under current law print advertising has to also disclose risks, and the safest approach for disclosing that risk is to publish the full package insert (PI) along with the print ad. As we know PIs are a tough read normally, but when shrunk down to fit in a magazine they are almost unreadable and certainly mostly incomprehensible to the very audience they are supposed to be protecting – consumers.

This has not been lost on the FDA and the guidance linked to above was entirely focused on resolving this issue.

In an FDA survey, few respondents reported reading half or more of the brief summary presented in the traditional format. Of those who read at least some of the brief summary, 55 percent described it as hard to read. Over 40 percent of respondents in the survey reported they do not usually read any of the brief summary in direct-to-consumer prescription drug print advertisements.

The FDA realizes that the full PI is aimed at medical professionals and full of details that the vast majority of consumers don’t care about like clinical pharmacology or chemistry. So the FDA is suggesting that manufactures should have the flexibility to replace the PI with something they are now calling “consumer brief summary.”

What is a consumer brief summary? Per the guidance it is an explanation written in consumer-friendly language (ie. drowsiness not somnolence) that includes:

  • Boxed warnings
  • All contraindications
  • Certain information regarding Warnings and Precautions:
    • The most clinically significant information from the Warnings and Precautions section(s) of the PI;
    • Information that would affect a decision to prescribe or take a drug;
    • Monitoring or laboratory tests that may be needed;
    • Special precautions not set forth in other parts of the PI;
    • Measures that can be taken to prevent or mitigate harm
  • Most frequently occurring Adverse Reaction, and those ARs that are serious or that lead to discontinuation of use, and the severity of the risk
  • Indications for use
  • Significant drug interactions

And this is where Medical Affairs comes into play. Now our commercial colleagues and their agencies are going to be needing to develop information that includes medical judgement, like:

  • What is the most clinical significant information?
  • Why is that information considered most clinically significant?
  • How do practitioners view what is most clinically significant?
  • What information should affect the decision to take or prescribe the drug?

These questions are great ones for Medical Affairs to either provide guidance, answer directly or gather information from practitioners during their interactions to answer these questions and others. Given the proper but strong firewalls between MA and commercial, this new guidance provides a value-added opportunity for MA to provide some guidance to commercial.

MA leaders may wish to discuss this topic with their commercial colleagues.

Do you have any thoughts on the new guidance? Leave them in the comments by clicking HERE and scrolling down to the comment box.

Topic 24: Highlights of Day 1 of the Medical and Scientific Communications 2013 Forum

As I mentioned earlier, I am attending the DIA MSC meeting in Pheonix, AZ this week.  The MSC has increased value this year because they have added a track specifically focused on MSLs.  Through the hard work of the MSL Track Chair people Rebecca Vermeulen and Ramineh Zoka, as well as the hard work of all the presenters the MSL Track has had a terrific first day.

DISCLAIMER:  My focus is on interesting information, I did not try to take verbatim notes and will not try to assign comments to a particular speaker.  Any mistakes are mine alone.

In no particular order, some of things are found interesting included:

–  A pill is poison unless the right information is wrapped around it.

–  ACA

  • Because of the passage of the ACA and the Supreme Court upholding the law, Rx spending is expected to increase 4.7% more than is the law had not passed
  • With the ACA’s introduction of roughly 20 million newly insured people in 2014, the US market will become the fastest growing pharmaceutical market in the world

–  Tax Deductibility for Marketing and Sales expenses in Biopharma

  • Some talk about eliminating this to increase tax revenue
  • Proposed 3 times in the last year but killed each time
  • NOT at all clear whether MA would be considered marketing under tax law
  • If passed, likely to see major cuts needed to balance budgets in these areas

–  Sunshine Act

  • Already happening for 16 companies under CIA’s
  • For a taste of the info that will be available, see this link
  • New PhRMA/Coalition formed to educate public about wave of new disclosure information coming called National Dialog for Healthcare Innovation

–  Caronia Ruling (you knew I would have to get something in here about this)

  • No one knows when it will be law of the land but likely 5 to 10 years
  • Old standard of safe – what is on the label
  • New standard will be – information that a reasonable consumer would not find misleading
  • New standard is current FTC standard for all advertisement
  • Data will be king, but not just data submitted to FDA
  • For time being, continue like no change

–  History of MSL Role

  • First MSLs started 40 years ago
  • Up John created role and actually trademarked the name MSL
  • Part of the sales teams – scientific sales

–  MSL Facts of Interest

  • Most MSLs manage between 25 and 49 KOLs
  • 32% of companies surveyed (n~60+) intend to grow MSL team
  • Only 11% intend to shrink MSL teams

–  Value of MSLs by Physicians

  • Surveys showed physicians do NOT value frequency, they value:
    • Accessibility
    • Responsiveness
    • Knowledge
    • Up to date information
    • Do NOT want to meet with MSLs if:
      • Only have old or out of date information
      • Feel they are biased
      • Have nothing new to tell them

–  Diagnostic MSLs

  • Specific MSL group focused on uptake of diagnostics
  • Big challenge – to use a diagnostic, they need the diagnostic platform – often millions of dollars
  • Thus broader array of people involved in decision beyond just HCP, including:
    • Bench Tech
    • Lab Managers
    • Pathologists
    • Administration
    • Opens questions about right regulatory regime for non-HCPs

–  CIA Driven Changes

  • CIAs require standards and documentation
  • Documentation increasingly taking the form of customer relationship management systems specifically for MA
  • Most common system by show of hands in the room: Veeva running on
  • To be effective, this type of system needs to:
    • Track interactions
    • Manage content
    • Link the two
    • Key pitfalls
      • Privacy, especially for global systems given EU requirements
      • Complexity

Obviously, this is merely a few key concepts from the day but it should give you some flavor of the type of discussions and the focus of the meeting.  Overall I would say the tone was very positive, given the challenges MSLs face in their highly regulated environment.  Everyone at the meeting was confident that MSLs value was high and these challenges could be met.  Look forward to tomorrow.

Topic 23: Key Implications for MA Leaders in the New Sunshine Act Rules

In previous posts this week I have broken down the key provisions of Sunshine Act rules.  Now I want to provide my thoughts on what this means for MA leaders and their teams.

Owning the Correction Process

Everyone who conveys something of value to a physician within biopharma will need to understand these rules and their part of tracking them.  This is a new administrative burden for many parts of biopharma.

BUT, there is one specific work activity that I want to address before I jump into implementation concerns.  When all this data is compiled and sent to CMS, the physicians will have a yearly chance to review it and offer corrections.  These corrections will need to be reviewed and discussed with the company.

So the big operational question is – Who is going to take point on that correction interaction?  Are we going to expect that the physician try to contact different functional areas within the company directly with their questions?  That may not be reasonable since the reported values will not make it clear who is responsible within the biropharma.

I am going to suggest that someone needs to take clear ownership of this responsibility and in the case of KOLs it should be MA.  MA should be responsible for serving as the point of contact for KOLs with these issues and driving the issues to resolution.  Non-KOL physicians should be handled by an administrative group in finance, but KOLs really need to handled carefully if we do not want to damage our relationships.

Overall Sunshine Implementation

To prepare for the Sunshine Act, MA needs to ensure the following:

  1. Internal systems are being built to properly capture this information
  2. MA personnel and specifically MSLs are receiving proper training to understand how and when to report this information
  3. A physician education program is developed and MA’s role in executing the physician program is clearly defined

I will highlight each of these elements and discuss related key Sunshine Act rules.

1. Internal Systems Developed for Sunshine Reporting

This is one area that MA probably has the least control.  These should already be underway and hopefully MA has already had a fair amount of say.  If MA is part of the stakeholder group that is reviewing these systems, I would ask the following questions based on my reading of the Sunshine Act rules:

  • Will the system cover all payments, even those related to OTC or other non-pharma products?
  • Is the company going to report in a consolidated fashion or separately by subsidiary/JV?
  • Is the organization going to add context statements to payments?  If so, which ones and when?
  • How many products will be associated with each payment?  Rules allow up to 5
  • Are we prepared to track corrections and resubmit within the 15 day window after corrections are due?

2. MA Personnel Training on Sunshine Reporting

There is a fair amount of nuance in the Sunshine Act reporting rules.  It is critical that training is developed that make the following clear to MA staff:

  1. Overall Payments
    • If value is provided to a physician but not at the request of the physician, it still needs to be reported.
    • Waived fees – of a physician suggests it is donated to a charity on their behalf it will still be tracked, unless they truly waive their fee without obligation to the company
    • All payments need to be coded by category – training is needed on the definition and difference (eg. travel vs. meals)
  2. Food
    • If a group meal is provided where the value is greater than $10 per person, each physician that actually partakes of the meal must be tracked
    • Unless the food provided at a large event, in which case it does not have to tracked
  3. Indirect Payments
    • Value provided to a third party but expected to be delivered to a physician must be tracked under the physician’s name
    • Value provided to an institution with the intention that it will go to a physician even if that physician is unnamed must be tracked (eg. providing funding to a teaching hospital for research grants will have to be tracked to the recipient physician)
    • Blinded payments to physicians for market research do not need to be tracked
  4. CME Programs
    • Accredited programs are exempt from reporting only if no names of speakers or even specific criteria for speaker selection is provided and the manufacturer does not pay the speakers directly
    • General subsidies for CME tuition does not have to be tracked
  5. Patient Education
    • Patient education materials and items are excluded from being tracked

3. Educating Physicians and Especially KOLs

It is vital that our KOLs are aware of the rules so that we can avoid confusion and bad feelings.  Some key elements of the rules that I believe every physician/KOL should know:

  1. General Rules of the Road
    • All value provided greater than $10 must now be reported, or multiple smaller transactions that add up to $100 in one year
    • All data is tracked and submitted yearly
    • Physician must register with CMS website to gain access to the data in their name
    • After registration, physician will receive notification when data is posted yearly about them
    • Physician will have 45 days after notifications to review data
    • Physician will go onto CMS website and enter any corrections they think are necessary
    • Manufacturer has 15 days to review the corrections submitted and accept or reject
    • If the manufacturer rejects the correction, the manufacturer and the physician are expected to negotiate and reach consensus
    • If consensus is not reached, the manufacturer value number is used but it is marked as “in dispute”
  2. Nuance of Value Tracking
    • Value tracked will include OTC and other non-pharma products from the company
    • If value is provided to a physician but not at the request of the physician, it still needs to be reported.
    • Value contributed to charity in their name will still be reported – eg. primary research honoraria donated to a cause is still considered value provided and will not be coded as charity contribution but as primary research honoraria
    • Tracking pierces the outsourcing veil – if a manufacturer pays a CRO and the CRO pays the physician, it tracks as the manufacturer paying the physicians
    • Reporting on research payments and value may be delayed for up to 4 years or until FDA approval, so do not be surprised if some clinical trial payments do not show up on the yearly total.  Similarly don’t be surprised to see multiple year’s worth of payments show up in one year after FDA approval, but they will be labeled with the year actually worked.

Topic 22: We Read the Sunshine Act Rules So You Don’t Have To – Part 2

This is the second part of my review of the Sunshine Act rules.  You can read all of the exciting  282 pages  here.  The first part of this analysis is here.

There are a lot of these so I will break this into a couple of posts and conclude by highlighting the ones I think are the most challenging to address.

  • Exclusions for Existing Personal Relationships (eg. husband [Pharma employee] give wife [physician] a string of pearls) will remain.  Pg. 111
  • Exclusion for transfers of $10 or below assuming that such transfers do not add up to over $100 during the course of the year remains in effect and the $10 amount will not be raised until 2014. Pg. 112
  • Small incidental items under $10 (eg. notepads, magnets) that are provided at large-scale conferences or events are exempt from tracking including for aggregate purposes. Pg. 114
  • Items intended for patient education will be excluded, even when they hold some potential alternative value for the physician (eg. providing a thumb drive containing patient education material). Pg. 116
  • Education materials that are targeted directly at a physician (eg. reference manual, text book) are not included in the patient education exception and thus their value must be tracked and reported. Pg. 117
  • The exclusion for “in-kind” value provided to a physician supporting the physician’s ability to provide “no charge” services to patients who cannot afford them includes patients that cannot afford the co-pay as well as patients simply unable to pay. Pg. 119
  • The exclusion allowing the short-term loan of a device has been clarified to be for only 90 days or less, even if the device is disposable and not used during the 90 days.  Additionally, the short-term loan is for a total of 90 days during a year, not a series of 90 day loans.  Pg. 122
  • Physicians that receive value as subject in a clinical trial do not have to have that value reported since they receive that value in their role as patient not physician.  Pg. 123
  • Indirect transfers of value or payments do not need to be tracked if the manufacturer is not aware of who the third-party they pay is providing value to.  If they are aware who the third party if providing value than they do need to report that value. Pg. 128
  • Indirect payments do have to be tracked if the manufacturer provides it with instructions that would lead it to be given to a covered physician.  For example, if a manufacturer provides a payment to a teaching hospital specifically to provide grants for research, that manufacturer would need to report who received the grants even if they are not involved in deciding who will receive the money.  If they provided the money to the same teaching hospital but put no restrictions on that money and the hospital decided to use some for grants they would not have to report it.  Pg. 131
  • Indirect payments where the manufacturer is not able to be aware of the payment recipient are excluded from reporting.  For example if a manufacturer hires a market research company to provide double-blind market research, they cannot know who received the value and as such they do not need to track the indirect payments. Pg. 134
  • Indirect payments that result in reporting are to be tracked for two quarters beyond the payment year.  For example if a teach hospital is given money for grants in March of 2013, it must track that money through the end of Q2 2014.  Money dispersed after that point does not have to be tracked.  Pg. 136
  • When industry funds CME, the speaker payments do not need to be tracked if the following is true 1) the CME events meets the ACCME, AMA or other major certification requirement, 2) the manufacturer does not provide suggested speaker names or even a list of suggested names/qualifications, 3) the manufacturer does not pay the speaker directly.  Pg. 140
  • When industry pays to subsidize the accredited CME attendees tuition fees it is exempt from reporting. Pg. 140
  • Payments make in connection with prescriber education beyond materials that is required by REMS must be reported like any other educational value provided. However, the value of “Dear Doctor” and other education materials is excluded.  Pg. 141
  • There is quite a bit about the definitions of stock and option ownership and investment interest that I am not covering in detail because I don’t think it relates extensively to MA.
  • While not required, the rules suggest that prior to report submission the individual physicans are provided with a report of what information is going to be sent in the report to provide them with an opportunity to make corrections.  Pg. 156
  • Reports are due by the end of Q1 of the following year. Pg. 157
  • Reports are to be accompanied by attestations of accuracy by the CEO or similar top company officer.  Pg. 164
  • Physicians and teaching hospitals will be notified that a new report is available and open to be reviewed and corrected generally through web postings at CMS, and directly if they register with the CMS ahead of time. Pg. 171
  • Physicians will be given 45 days after notification and before publication to go online and review the data about to be published and submit corrections. Pg. 172
  • Manufacturers only have 15 days after the 45 day review period to correct their data and resubmit to CMS.  Pg. 173
  • To receive the data for review, physicians will need to register and validate their identify. Pg. 174
  • Physicians who dispute the data provided by a manufacturer in their name must resolve the issue directly with the manufacturer.  The physician will be able to enter their suggested correction in the CMS database and CMS will provide the suggested correction to the manufacturer but will not be engaged in issue resolution. Pg. 180
  • If the physician and the manufacturer cannot come to an agreement within the 15 day correction period, the transaction will be marked as disputed but the manufacturer’s original data will be displayed.  Pg. 184
  • The CMS will update the database at least once after the initial publication to reflect corrected data that arrives after the initial correction period. Pg. 185
  • Reporting on payments made to support development of new drugs, devices, biologics or medical supplies can be delayed until FDA approval or 4 calendar years, whichever comes first. Pg. 194
  • The delayed reporting is only applicable for new drugs, any development of new indications on existing approved drugs is not subject to the delay. However, new generics will be considered new drugs for reporting purposes. Pg. 196
  • Reporting is required even for products that fail in development, after the 4 year time period has expired. Pg 198
  • Delaying the report of value provided for new drug development is optional – the manufacturer still has to report the amount of value provided and then may choose to request that the reporting be delayed.  Pg. 199
  • Information will be maintained on the CMS databases for 5 years after publication date. Pg. 206
  • The new Federal rules will pre-empt state reporting rules after the Federal rules go into effect. Pg. 211
  • Rest of report is Federal administrative analysis, not relevant in terms of rule execution.

I will analyze what this means for MA leaders and their team in a subsequent post.  Please leave your comments below.

Topic 22: We Read the Sunshine Act Rules So You Don’t Have To – Part 1

We have been discussing the Sunshine Act here on the MA Focus blog for awhile.  The much delayed rules of have finally been released – all 282 pages!  And, boy, are they exciting reading!

Biopharma is to begin collecting this data on August 1, 2013 with the first set of reports due to CMS on March 31, 2014.  So, to the degree your teams will need to be educated on what to capture and how to report, there is actually very little time to set up the systems you need.

As a result, even if these rules are not exciting reading, they are important.  I have reviewed them and identified some highlights that I think will be important to everyone in MA.  I summarize the highlights below along with page references if you want to read all the riveting detail.  There are a lot of these so I will break this into a couple of posts and conclude by highlighting the ones I think are the most challenging to address.

  • Unrelated Products – the rule makes clear that you must track all payments (direct and indirect) made to a physician even if those payments are related to a product not covered by the act (eg. a product still in development, an OTC product)  pg. 19
  • If a company is bringing its first covered product to market (meaning its first FDA approved drug or device) then after the approval it has 180 days before it is expected to begin reporting.  Pg.21
  • If a company has subsidiaries or JVs as defined in the statute it has the option to provide its reporting either individually or in a consolidated fashion.  Pg. 27
  • Companies do not need to report on non-physician prescribers, like Nurse Practioners, unless those non-physician prescribers pass the payment or value they receive through to a physician.  Pg. 37
  • The “employee exemption” has been clarified to exclude physicians so an organization cannot claim that a physician is an employee and thus not report on that physician.  Pg. 39
  • Payments to non-healthcare departments of universities affiliated with teaching hospitals are excluded from reporting. Pg. 41
  • All physician information must include name (first, last, middle initial), address, specialty and NPI number.  Additionally, you must report state professional license numbers(s) for at least one state. Pg. 44
  • Value provided that is transferred to another entity at the request of or the benefit of the physician must be reported under the physician’s name.  For example, a payment to a group practice at the request of physician is reported under the requesting physician’s name. Pg.51
  • If value is provided to a physician but not at the request of the physician, it still needs to be reported. Pg. 52
  • Value provided directly to a group of physicians (eg. practice) that are not a covered entity (eg. teaching hospital) will need to be divided among all the physicians in the practice or following some “fair” approach determined by the manufacturer.  Pg.  53
  • Value provided to one covered entity (eg. teaching hospital) but directed by the manufacturer to a physician within the hospital are to be reported against the physician, not covered entity. Pg. 54
  • If a physician or covered entity waives their payment, they need to be clear whether they want it sent to a third party (eg. charity) “on their behalf.”  If so, it will be reported as value received by the physician.  If not, even if the manufacturer donates it, it should not be reported. Pg. 59
  • Manufacturers may provide a brief context statement for each payment but it’s optional.  Pg. 66
  • Manufacturers can report up to 5 products related to a payment or transfer of value using NDC numbers when available.  Pg. 70
  • The nature of each payment needs to be coded into pre-set categories (eg. Consulting , honoraria, gift, education, meals, grant, travel) and when a payment crosses the approved categories it is up to the manufacturer to decided which one is most appropriate. However, if the payments for each category is discrete (eg. meal vs. plane ticket) the payments should be reported separately and coded individually. Pg. 75
  • In the case where a physician requests their payment be made to a charity, the nature of the payment category is not “charitable contribution” but it is the category for the actual value provided (eg. consulting fee, grant) Pg. 82
  • For Food/Beverage, if the manufacturer provided food at a group setting other than a conference, the manufacturer has to track the value of the per person cost (total meal cost divided by total number of people partaking) if it exceeds $10 but only for those physicians that partake in the meal (eg. drink the coffee, eat the sand which). Pg. 85
  • Research payments are those associated with a broad definition of research including preclinical, P1-4 and IIS, and applies when there is a contract for research AND/OR a research protocol. Pg. 101
  • The requirements pierce the outsourcing veil – meaning that a payment made by a manufacturer to a CRO, who pays SMO, who pays the physician – would be tracked as a payment by the manufacturer to the physician for the amount the physician receives. Pg. 101
  • Research payments will be tracked by providing the name of the covered entity (eg. hospital) and the name of the principle investigators (PIs) associated with the research. Pg. 105

End of Part 1 – Only 177 Pages to Go!

Update: Caronia and Off Label Promotion – The Beat Goes On

At a recent CBI compliance conference in DC, Tom Abrams, director of the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) basically said that as far as his agency was concerned nothing was going to change in their enforcement of off-label promotion.  His rationale is, in my non-legal opinion, in the vein of “it depends on what the definition of ‘is’ is”.  I think OPDP has chosen to see what they want to see in the ruling, but regardless they are not changing their approach or tactics.

Take a look at his full statement below:

The government has determined not to seek further review of the Second Circuit’s decision in United States v. Caronia, No. 09-5006-cr (2d Cir.).  FDA does not believe that the Caronia decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug, and Cosmetic Act (FD&C Act).

In 2009, Alfred Caronia was convicted of conspiring to distribute a misbranded drug in violation of the FD&C Act.  A divided panel of the Second Circuit held that the jury instructions erroneously permitted, and that the government’s argument encouraged, the jury to treat speech promoting unapproved (off-label) uses of an FDA-approved drug as a criminal offense in and of itself.  The court of appeals did not address the constitutionality of the theory of liability on which the government had defended the conviction:  namely, that the promotion of a drug for an unapproved use may be relied on as evidence that the unapproved use is an intended one, and a drug that lacks adequate directions for its intended uses is misbranded.

Because the court did not address the constitutionality of a prosecution resting on that theory, and because the court also acknowledged that the First Amendment does not preclude an enforcement action based on speech regarding unapproved uses that is false or misleading, the Second Circuit’s decision does not bar the government from continuing to enforce the misbranding provisions of the FD&C Act, including through criminal prosecution where appropriate, in cases involving off-label promotion.  More generally, the decision does not strike down any provision of the FD&C Act or its implementing regulations, nor does it find a conflict between the Act’s misbranding provisions and the First Amendment or call into question the validity of the Act’s drug approval framework.

Bottom line, they are sticking with the belief that while anyone has the “right” to promote off-label, doing so ultimately leads to misbranding which is in violation of the FD&C act.  How you square this with the Second Circuit’s ruling that there is protection for promoting off-label as long as the information provided is true will be an argument that will, no doubt, end up back in court.  I’m not a lawyer but I thought my rights trump your laws.

But for now off-label promotion remains open to OPDP enforcement.

What are your thoughts?

h/t PharmaExec Blog

QuickNote: Off Label Promotion Ruled OK by US District Court

In a ruling with huge potential impact on MA as well as commercial functions, the Court of Appeals for the Second Circuit in Manhattan has overturned a conviction of a salesperson who was promoting the off-label use of a product! This 2-1 ruling goes against years of court rulings stating that pharma does not have the right to promote off-label.  In fact,  in the past month GSK has been fined $3 billion for off-label promotion and J&J fined $181 million for off label promotion.

Clearly, new legal ground is being broken here.  BUT, if urge caution.  This is one ruling that contradicts years of previous rulings.  It may serve as grounds for kicking this up to the Supreme Court, but until clear legal direction is given I would not be changing any policies.

Take a look at the article here and the actual ruling here.