Pharmaspective

Understanding the Global Transparency Landscape: The Beginning of An Ongoing Journey

By Brian P. Sharkey

The quest for transparency in the relationships between life sciences companies and healthcare professionals has become a global movement, as companies are beset by a multitude of obligations designed to make public their interactions with their customers.  Effectively managing those obligations while concurrently ensuring compliance with the growing body of international transparency requirements and anti-corruption legislation is a significant challenge to the continued growth and success of life sciences companies.

 

For a number of years, pharmaceutical companies doing business in the United States have dealt with a host of states that impose limits and reporting obligations on interactions with healthcare professionals.  Device companies were brought into the fray more recently when several states expanded the applicability of their laws.  However, the past two years have seen the rise of transparency challenges throughout the world.  Two countries, France and Slovakia, have enacted laws similar to the US Sunshine Act.  In other countries, reform is taking place through industry codes enacted by the relevant industry association.  Pharmaceutical industry codes including reporting requirements have been enacted in a number of countries, including, significantly, the Netherlands, the United Kingdom, Japan, and Australia.  The transparency trend has not affected the medical device industry as much yet, as medical device industry associations have yet to impose reporting requirements in their codes.

 

It is widely anticipated that numerous countries will join this growing trend.  The key question for the life sciences industry is whether reporting requirements will be imposed through governmental action or voluntary industry self-regulation.  Although a self-regulatory solution would likely be more consistent and efficient than a plethora of disparate legislative obligations, in either case it is imperative for life sciences companies to monitor which approach is adopted in individual countries and regions.

 

Another transparency challenge facing the life sciences industry is the burgeoning body of anti-corruption laws.  Although these laws are distinct from the transparency codes and laws, in no small part because violations can lead to criminal penalties, anti-corruption laws relate to transparency requirements in two ways:  1) both are aimed at rooting out corruption and reducing the cost of doing business; and 2) the increase in transparency reporting can provide ammunition to prosecutors in seeking indictments.

 

The purpose of this post is not to explore these global challenges; rather, it is to introduce these issues to our loyal readers and outline how we will be addressing them going forward.  We envision periodic posts about these types of global compliance issues –for example, we may highlight the transparency requirements in Australia’s pharmaceutical industry code; or discuss the United Kingdom’s Bribery Act; or analyze Eucomed’s White Paper on transparency issues.  Unfortunately for companies in the life sciences industry, the possibilities for topics that we can cover is endless.  We intend to do our best to span the globe and keep you informed about the latest news and trends in this evolving area, and we welcome your feedback about how you may dealing with these challenges.

 

An Update From CMS on the Sunshine Act…Draft Templates!

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) announced the release of the final regulations implementing the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act, commonly referred to as the "Sunshine Act." The final rule was published in the Federal Register today, and will become effective on April 9, 2013.

 

The Sunshine Act requires applicable manufacturers of covered drugs, devices, biological products, and medical supplies to report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires applicable manufacturers and group purchasing organizations (GPOs) to report all ownership and investment interests held by physicians or members of their families. As set forth in the final regulations, applicable manufacturers and GPOs must begin data collection on August 1, 2013, and must file their first reports on March 31, 2014.

 

In preparation for reporting, CMS has posted on their website the following proposed templates for data collection and submission of reports required by the Sunshine Act:

 

-  Non-Research Payment Template;

-  Physician Ownership Template; and

-  Research Payment Template

 

Additionally, CMS has set up a “National Physician Payment Transparency Program: OPENPAYMENTS” website. This website will provide ongoing information and updates on the Sunshine Act, including:

 

- General information

- Fact sheets

- Tools and instructions

- Resources

- Dates of webinars, calls and meetings

- Frequently asked questions

 

Stay tuned!

 

Don't forget to check out our other posts regarding the Sunshine Act Final Regulations:

The Who and the What of the Sunshine Act Regulations,Sunshine Act: Reporting Food, CME, and Research...Oh My! and Sunshine Act: Indirect Payments: Reportable or Excluded?

FDA May Change Regulations to Allow Generics to Change their Product Warnings

By Frank Fazio and Genevieve Spires

@frankfaziopls    @gmspires

A single footnote in a brief filed by the Department of Justice has garnered a lot of attention this week, and understandably so.  The footnotes states: “This office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances. If such a regulatory change is adopted, it could eliminate preemption of failure-to-warn claims against generic-drug manufacturers.”

The background of this statement is complex, but briefly, the United States Supreme Court ruled last year that plaintiffs claiming injuries as a result of their use of generic drugs may not sue generic manufacturers for their failure to warn of an alleged drug-related danger.  In deciding this, the Court found that these claims are preempted – and therefore barred – by federal law, largely because generic manufacturers are not permitted to make changes to their product labels under the current regulatory scheme (even in cases where they think stronger warnings are needed).

Under current FDA regulations, generic manufacturers cannot unilaterally update their product labeling.  Only brand-name manufacturers have the ability to update warnings on product labeling and must get FDA approval to make those changes.  Generic manufacturers are required to adopt the warnings of their  brand-name counterpart.

Any change in regulations to allow generics to change their labels will undoubtedly reopen the litigation floodgates and result in a slew of failure to warn cases being brought against generic drug manufacturers.   Likewise, such a rule can result in inconsistencies in warning information on the same drug which can certainly result in increased liabilities for those companies who fall behind in regard to labeling updates adopted by competitors.  And while we do not know the source of the information referenced in the DOJ brief, we will definitely stay tuned to see if Congress takes steps to alter the generic drug label regulatory scheme.

The Final Sunshine Act Regulations Have Been Published in Federal Register, and Will Become Effective on April 9, 2013

By Hiramella Deonarine

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) announced the release of the final regulations implementing the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act, commonly referred to as the "Sunshine Act." The final rule was published in the Federal Register, and will become effective on April 9, 2013.

 

The Sunshine Act requires applicable manufacturers of covered drugs, devices, biological products, and medical supplies to report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires applicable manufacturers and group purchasing organizations (GPOs) to report all ownership and investment interests held by physicians or members of their families. As set forth in the final regulations, applicable manufacturers and GPOs must begin data collection on August 1, 2013, and must file their first reports on March 31, 2014.

 

In addition to releasing the final regulations, CMS also released a Fact Sheet providing, among other things, a summary of the reporting requirements, the implementation timeline, and information regarding research payments. In response to CMS’ release of the final regulations, Senator Charles Grassley, co-author of the Sunshine Act, made the following statement:

 

“Disclosure brings about accountability, and accountability will strengthen the credibility of medical research, the marketing of ideas and, ultimately, the practice of medicine. The lack of transparency regarding payments made by the pharmaceutical and medical device community to physicians has created a culture that this law should begin to change substantially. The reform represented by the Grassley-Kohl Sunshine Law is in patients’ best interests. I will stay vigilant about how this law is implemented, especially after the delays seen already. The goal is straightforward, and CMS needs to make certain the reporting and disclosure are complete and clear.”

 

For additional information on the Sunshine Act and to view a copy of the final regulations as released by CMS on February 1, 2013, please see visit the Federal Register website. 

 

Don't forget to check out our other posts regarding the Sunshine Act Final Regulations:

The Who and the What of the Sunshine Act Regulations; 

Sunshine Act: Reporting Food, CME, and Research...Oh My!; and

Sunshine Act: Indirect Payment: Reportable or Excluded?

 

 

Sunshine Act: Indirect Payments: Reportable or Excluded?

By Sarah Canberg

All too often, a payment from an applicable manufacturer does not go directly to a physician or teaching hospital. Instead, the applicable manufacturer indirectly provides a payment to a covered recipient by making a payment to a third party that then transmits the payment to the covered recipient that actually performed the services (e.g., a pass through payment). Alternatively, a covered recipient may request that the applicable manufacturer provide the payment to a third party “at the request of” or “on behalf of” a covered recipient rather than the covered recipient receiving the payment.  The actual recipient of the payment is often a charitable entity. The final Sunshine Act regulations acknowledge these payment streams and, as a general requirement, mandate the reporting of these payments to physicians and teaching hospitals as well as payments to non-covered entities or individuals “at the request of “ or “on behalf of” a physician or teaching hospital. Yet, there are notable nuances and exceptions to the rule.

Indirect Payments: What Are They? When Are They Reportable?

In an effort to clarify when an indirect payment is subject to reporting, the final regulations include a definition of “indirect payments or other transfers of value”:

payments or other transfers of value made by an applicable manufacturer…to a covered recipient…through a third party, where the applicable manufacturer…requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient(s)….

The preamble includes an example of an applicable manufacturer providing an unrestricted donation to a physician professional organization for use at the organization’s discretion.  In turn, the organization uses the funds to provide a grant to physicians.  Since the applicable manufacturer did not require, instruct, direct, or otherwise cause the recipient of its donation, the organization, to use the funds for grants to physicians, this does not fall within the regulatory definition of “indirect payment or other transfer of value” and, as such, is not reportable as either a direct or indirect payment to a covered recipient.  On the other hand, if the applicable manufacturer provides a donation to the organization with an earmark for the payment to be used to provide grants to physicians, this would constitute an indirect payment reportable against the ultimate covered recipient.  This is so even if the manufacturer did not specify or suggest which physicians would receive the grants.

Payments “At the Request Of” and “On Behalf Of”: Follow the Money

It is not unusual for a physician or teaching hospital to request that an applicable manufacturer to provide a payment to a third party rather than directly to the covered recipient.  An example would be the request that the payment be provided to the physician’s practice or an affiliated entity rather than directly to the physician.  In circumstances such as this, the covered recipient is directing the path of the payment, not the applicable manufacturer.  The final regulations require that such payments must be reported in the name of the covered recipient.  The name of the entity that received the payment or, if an individual, the word “individual” would also be included in another field on the disclosure report.

A physician or teaching hospital may also direct an applicable manufacturer to provide a payment to a charitable entity as a donation on behalf of the covered recipient.  Similar to the above scenario where the payment is directed to a third party “at the request of” a covered recipient, when a covered recipient directs a payment be made to a third party, such as a charity, “on behalf of” the covered recipient, such payment must be reported in the name of the covered recipient; the disclosure must also include the name of the charity that received the payment at the direction of the covered recipient.

Indirect Payments: Exclusion Provision

Although the Sunshine Act and regulations provide an exclusion of indirect payments to third parties, this is applicable in very limited circumstances.   In order for an indirect payment to be excluded from reporting, the payment must (1) qualify as an indirect payment or transfer of value, and (2) the applicable manufacturer must be unaware of the identity of the physician or teaching hospital receiving the payment during the reporting year or by the end of the second quarter of the following report year. 

For an applicable manufacturer to be “unaware” of the identity of the physician or teaching hospital receiving the indirect payment, the applicable manufacturer must not have actual knowledge or act in deliberate ignorance or in reckless disregard of the truth or falsity of the information.

The preamble specifically provides that for this exclusion only, when an applicable manufacturer makes a payment to a third party with the intent of keeping the identity of the covered recipient anonymous, the applicable manufacturer will not be acting in deliberate ignorance or reckless disregard of the identity of the covered recipient and will be deemed “unaware” of the identity of the covered recipient.  The specific example provided is the engagement of a market research firm to conduct a double-blinded market research study.  The payment to the firm, part of which may ultimately go to physicians for participation in the research, would qualify as an indirect payment excluded from reporting because the physicians are intended to be anonymous in their participation.

Where a payment is made to a third party, and the third party is directed to make payments to an identifiable group of covered recipients, such as the top billing cardiologists in a certain city, the applicable manufacture would be deemed “aware” of the covered recipients and required to report against such covered recipients assuming that the covered recipients can be identified during the reporting year or through the second quarter (June 30th) of the subsequent year following the transfer of the payment to the covered recipient by the third party.  The applicable manufacturer must report such indirect payments in the calendar year that the third party provided payment to a covered recipient and the applicable manufacturer became aware of the identity of the covered recipient. For example, the applicable manufacturer makes a payment to a third party on August 31, 2013, but the third party provides the payment to a covered recipient on December 31, 2013.  Further, the applicable manufacturer does not become aware of the identity of the covered recipient until early in calendar year 2014.  In this circumstance, the payment would be reported for calendar year 2014. We view this example of reportable indirect payments as the most troublesome and potentially difficult for applicable manufacturers to track.  In this scenario, the applicable manufacturer must track the payment being provided by the third party, identify the covered recipient, and report payments provided by the third party to a covered recipient in the subsequent calendar year.

 

For additional information on the Sunshine Act and to view a copy of the final regulations as released by CMS on February 1, 2013, please see visit the Federal Register website. 

 

Don't forget to check out our other posts regarding the Sunshine Act Final Regulations:

The Who and the What of the Sunshine Act Regulations and Sunshine Act: Reporting Food, CME, and Research...Oh My!

Sunshine Act: Reporting Food, CME, and Research…Oh My!

By Sarah Canberg

 

As the life sciences industry continues to prepare to begin collecting data on payments and transfers of value to physicians and teaching hospitals on August 1, 2013, applicable manufacturers look for clarity and guidance on the scope of information to be reported. The final Sunshine Act regulations and lengthy preamble include numerous revisions to the draft regulation.  Here, we focus on a few key special rules for reporting food and beverage in a group setting, payments or transfers of value to accredited continuing education providers, and payments for research.

 

Allocating Food and Beverage in Group Setting

The final regulations modified how applicable manufacturers are to capture and report food and beverages provided to covered recipients in a group setting.  Applicable manufacturers are to report the cost of the group meal by allocating the cost per person, not the cost per covered recipient, to each covered recipient “who partook in the meal,” which is a substantial change from the draft regulations.  For example, if an applicable manufacturer brings a platter of sandwiches to a doctor’s office that costs $150 and 5 physicians and 5 office staff members participate in the meal, the applicable manufacturer  must report the cost per person ($150/10 = $15) for each of the 5 participating physicians. This is a common sense approach to reporting meals in a group setting.

 

Exclusion of Speaker Payments for Qualifying CME Programs

In recognition of the unique and important role of industry support for accredited or certified continuing education, CMS excluded payments to speakers participating in qualifying continuing medical education (CME) programs from reporting requirements.  For speaker compensation to be excluded from Sunshine Act reporting requirements, all of the following conditions must be met:

 

(1)    the program meets the accreditation or certification requirements for continuing education of one of five specifically listed organizations (e.g., the Accreditation Council for Continuing Medical Education (ACCME));

(2)    the applicable manufacturer does not select the covered recipient speaker or even provide a distinct list of potential speakers to be considered by the CME provider; and

(3)    the applicable manufacturer does not pay the covered recipient directly.

 

If all of the above conditions are met, the payment to the covered recipient to serve as a speaker at the qualifying CME program will not be subject to reporting.  On the other hand, if the above conditions are not met, such payment must be reported under the either of the appropriate nature of payment categories:

 

• “Compensation for serving as faculty or as speaker for an accredited or certified continuing education program,” or

• “Compensation for serving as a faculty or as a speaker for a unaccredited non-certified continuing education program.” 

 

Special Rules for Reporting Research

Following the publication of the draft Sunshine Act regulations in December 2011, the lack of clarity surrounding the reporting of research payments caused confusion and concern throughout the life sciences industry.  With the release of the final regulations, CMS’ substantial modification of reporting requirements for research-related payments reflected thoughtful revisions aimed at capturing the actual payment stream for research. 

 

In the final regulations, CMS removed the requirement for the applicable manufacturer to indicate whether the payment was direct or indirect, which was a source of much of the confusion in the draft regulations and concern that many payments would be double reported.  Instead, the final regulations require that research payments be reported separately from other reportable payments and transfers of value.  Further, research payments are to be reported as a single payment including the name of the individual or entity that actually received the payment for the research services and indicating the principal investigator(s) of the applicable research payment.  For example, if an applicable manufacturer provides payment to a CRO, and the CRO provides the payment to the academic institution conducting the research that involves Dr. John Smith as the principal investigator, the applicable manufacturer will report the payment as a single payment to the academic institution and include Dr. John Smith as the Principal Investigator in that single reportable interaction.  The final regulations require specific information to reported regarding the research payment, such as the name of the research study and the names of the related covered product (and National Drug Code if a drug or a biological), but also provides the option for the applicable manufacturer to provide context for the research payment.

 

While the regulations set forth the data elements that must be collected and reported for each of the above interactions, we look forward to reviewing the report layout, especially as related to the section for research-related payments.

 

For additional information on the Sunshine Act and to view a copy of the final regulations as released by CMS on February 1, 2013, please see visit the Federal Register website. 

 

Don't forget to check out yesterday's post for The Who and the What of the Sunshine Act Regulations.

The Who and the What of the Sunshine Act Regulations

By Sarah Canberg

With the long awaited Sunshine Act final regulations in hand, members of the life sciences industry continue to sift through the 285 page regulatory tome to parse out the regulatory reporting requirements that resulted from Centers for Medicare & Medicaid Services’ (CMS) consideration of over 373 comments from medical professionals and organizations, industry members and organizations, consumers, and others. While we do not attempt to summarize the entirety of the final regulations here, we highlight a few key changes to definitions and modifications to reporting requirements.

 

The Who

The first step for many in the life sciences industry is an evaluation of whether their company has an obligation to comply with the Sunshine Act.  In making this determination, the company must determine if their operations fall within the definition of an “applicable manufacturer” of a “covered drug, device, biological, or medical supply” which is operating in the United States.  The final regulations provide clarification and details regarding these two key definitions.

 

“Applicable Manufacturer”

Here, we highlight a few noteworthy clarifications included in the preamble regarding the scope of who is included and excluded within the definition of “applicable manufacturer.”  The regulatory definition of applicable manufacturer includes distributors and wholesalers that take title to a covered drug, device, biological or medical supply.  As a result, these entities are subject to the reporting requirements.  While distributors that do not take title to covered products do not fall within the definition of applicable manufacturer and are not subject to reporting.  It is important to note that distributors that qualify as “applicable manufacturers” have an independent obligation to submit reports pursuant to the Sunshine Act. 

 

The final regulations confirm the “all in” concept that requires a company that falls within the definition of an applicable manufacturer to report all payments or transfers of value to covered recipients regardless of whether the payments are related to covered products.  Yet, the final regulations provide that if an applicable manufacturer has less than 10% of its total (gross) revenue from covered drugs, devices, biologicals or medical supplies during the previous fiscal year, then the applicable manufacturer may report payments or other transfers of value related only to its covered products.

 

Further, if an applicable manufacturer has separate operating divisions that do not produce covered products (the example provided is an animal health division), the final regulations state that such divisions will only be required to report payments or other transfers of value related to the company’s covered products.

 

“Covered Drug, Device, Biological or Medical Supply”

The definition of “covered drug, device, biological or medical supply” includes two parts: (1) a drug, device biological or medical supply for which payment is available under Medicare, Medicaid, or CHIP, either separately or a bundled payment), and, if a drug or biological, requires a prescription, or, if a device, requires premarket approval or premarket notification to the FDA.  To  qualify as a “covered drug, device, biological or medical supply,” the product must satisfy both parts of this definition.

 

The What

“Indirect Payments or Other Transfers of Value”

In response to comments seeking clarification on which indirect payments or transfers of value are subject to the exclusion and which must be reported, CMS confirms that some indirect payments will be subject to reporting.  Specifically, the statutory exclusion of indirect payments turns upon the whether or not the applicable manufacturer is aware of the covered recipient of such payment.  If the applicable manufacturer is aware of the identify of the covered recipient, then the payment or transfer of value must be reported. In the preamble to the final regulations, CMS notes that excluding from the reporting requirements all payments made through a third party would create a  significant loophole by allowing manufacturers to funnel payments through a third party and not report them; such a loophole would significantly undermine the intent of the reporting requirements.  (pg. 28)

 

CMS further clarifies that if a covered recipient requests that an applicable manufacturer make a payment to a third party, and the third party then provides the payment to the covered recipient, the applicable manufacturer has an obligation to report such indirect payment or transfer of value against the covered recipient. This example of a reportable indirect payment differs from the situation where an applicable manufacturer provides a payment to a third party, and the third party provides a payment to a covered recipient without the applicable manufacturer’s knowledge or direction, which would fall within the indirect payment exclusion. For example, if an applicable manufacturer makes a payment to a consulting firm and, unbeknownst to and without direction from the applicable manufacturer, the consulting firm employs and pays a physician to work on the project, the applicable manufacturer would have no obligation to report such indirect payment from a third party to a covered recipient.

 

Be sure to visit our blog later this week for further analysis and discussion highlighting key provisions in the final regulations.

 

For additional information on the Sunshine Act and to view a copy of the final regulations as released by CMS on February 1, 2013, please see visit the Federal Register website. 

CMS Announces the Release of the Final Regulations Implementing the Sunshine Act...Finally!

By Chrissy Bradshaw and Sarah Canberg

On Friday, February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) announced the much anticipated release of the final regulations implementing the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act, commonly referred to as the “Sunshine Act.”  It is anticipated that the final rule will be published in the Federal Register on Friday, February 8th, and will be effective 60 days later on April 9th.

 

The Sunshine Act requires applicable manufacturers of covered drugs, devices, biological products, and medical supplies to report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires applicable manufacturers and group purchasing organizations (GPOs) to report all ownership and investment interests held by physicians or members of their families. CMS published proposed regulations in the Federal Register in December 2011. In response, CMS received approximately 373 comments from medical professionals and organizations, industry members and organizations, consumers, and others.  As set forth in the final regulations, applicable manufacturers and GPOs must begin data collection on August 1, 2013, and must file their first reports on March 31, 2014.

 

Along with the final regulations, CMS is publishing an extensive preamble that outlines and responds to many of the public comments submitted in response to the proposed Sunshine Act regulations.  The preamble and final regulations offer clarification and, where applicable, revisions to many provisions included in the Sunshine Act and proposed regulations.  In addition, several procedures and requirements changed significantly from the proposed regulations to the final version of the rule.  For many, the proposed Sunshine Act regulations likely raised more questions than provided answers.  The final regulations and the extensive preamble language provide some much needed clarity and guidance as the life sciences industry prepares for commencement of data collection and compliance with reporting obligations required by the Sunshine Act.  Of note, the final regulations include:

 

• Substantial clarification and revision to the definition of “applicable manufacturer,” including rules for contract manufacturers, distributors and wholesalers, and divisions within an applicable manufacturer;
• Amended or clarified rules for reporting certain categories of payments or other transfers of value, specifically:
  • Research-related payments,
  • CME support, and
  • Food and beverage costs;
• The addition of and clarification around certain data elements on the disclosure report, including:
  • The addition of state license number and licensing states for physician covered recipients,
  • Reporting the NPI number and use of the NPPES database,
  • Ability to provide contextual information related to payments, and
  • Allowing up to five covered products with each reported payment;
• Specific requirements and procedures for applicable manufacturer and GPO registration and reporting, such as:
  • Providing two points of contact, and
  • Flexibility and liability for consolidated reporting; and
• Additional details about the dispute process, including communication by CMS and timing for resolving disputes.

 

For additional information on the Sunshine Act and to view a copy of the final regulations as released by CMS on February 1, 2013, please see visit the Federal Register website.

 

Be sure to check back later this week for a more in-depth overview highlighting key provisions in the final regulations. 

 

A Quick Observation Regarding the FDA and the Caronia Decision…

By Kim C. Capone and Sarah M. Canberg

On December 3, 2012, the United States Court of Appeals for the Second Circuit handed down its decision in U.S. v. Caronia,  and ruled that the government cannot prosecute pharmaceutical manufacturers for speech promoting the lawful, off-label use of an FDA-approved drug.  Coincidently, the Food and Drug Administration (FDA) has not issued any Warning or Untitled Letters since the Caronia decision.  In 2012, the FDA issued twenty-eight enforcement letters.  The most recent was an Untitled Letter dated November 27, 2012, to Salix Pharmaceuticals, Inc. and Napo Pharmaceuticals, Inc. regarding its website and podcast for the investigational new drug, Crofelemer.

 

Although the Caronia decision only applies in three states, the FDA may have to change its approach regarding off-label marketing concerns.  In the past, it was enough for the FDA to allege in its letters that false or misleading speech was used to market drugs off-label.  Will the FDA now have to prove off-label marketing and make it clear that promotional statements were offered as evidence of intended use? 

 

The Wall Street Journal reported on January 23, 2013, that according to FDA officials, the government will not appeal the Caronia decision, and the 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." In the meantime, should we expect FDA to issue guidance regarding off-label speech, issue new off-label speech regulations, or continue with business as usual? The next Warning or Untitled Letter from FDA may provide some guidance as to FDA’s position with regard to off-label speech.

 

Link: U.S. vs. Caronia decision