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.

 

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.

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. 

Vermont Attorney General’s Office Posts Final “Guide to Vermont’s Prescribed Products Gift Ban and Disclosure Law for 2013 Disclosures”

By Hiramella Deonarine and Danielle Burke

In an effort to help manufacturers comply with the requirements of Vermont's Prescribed Products Gift Ban and Disclosure Law (Law) and to provide additional guidance for expenditure reports due on April 1, 2014 (the 2013 calendar year), the Vermont Attorney General's Office (AG’s Office) has posted on its website the final “Guide to Vermont’s Prescribed Products Gift Ban and Disclosure Law for 2013 Disclosures” (Guide).  Additionally, the AG’s Office posted the 2013 Expenditures Disclosure Form for 2013, and the Samples Disclosure Form for 2013.

Pursuant to the Law, manufacturers of prescription drugs, biological products, and medical devices are required to disclose to the AG's Office the value, nature, purpose, and recipient of any allowable expenditure or permitted gift. Manufacturers are also required to submit samples disclosure reports that include the product, recipient, number of units, dosage, and other information for all samples provided to health care providers.

In addition to the Guide, the AG’s Office also released a memorandum entitled “Common Errors in Compliance with Vermont’s Prescribed Products Gift Ban and Disclosure Law That May Result in Enforcement Action” (Common Errors).  This memorandum lists common errors made by manufacturers in previous disclosure reports submitted to the AG’s Office.  The Common Errors memo states that the AG’s Office “expects to take enforcement action against manufacturers with unjustified, obviously and egregiously incomplete or incorrect submissions.”

To view a copy of the Guide, the forms, and the Common Errors memo, please see the links above or visit the Vermont AG’s Office’s website. 

The Trend Towards Global Transparency: A Challenging New World for the Life Sciences Industry

Please click here to view a copy of “The Trend Towards Global Transparency: A Challenging New World for the Life Sciences Industry,” prepared by D. Jeffrey Campbell and Brian P. Sharkey for distribution at CBI’s 6^th Annual Forum on Sunshine and Aggregate Spend.  

For additional information on the authors, please click on their names below:

D. Jeffrey Campbell, Esq., Principal, Porzio, Bromberg and Newman, P.C.

Brian P. Sharkey, Esq., Counsel, Porzio, Bromberg and Newman, P.C.

Maryland Device Manufacturer Licensing – Form Over Substance

“The way to get started is to quit talking and begin doing.” - Walt Disney

 There are certain fundamental truths within state regulatory frameworks.  One such truth is that some statutes or regulatory requirements are inexplicable.  These requirements leave you scratching your head muttering to yourself “what were they thinking?”  The answer to that rhetorical question is that sometimes they weren’t thinking.  State legislative bodies make mistakes.  A statute or regulation generally makes sense to those who sponsor and support it.  It often isn’t until companies attempt to comply that the error or omission comes to light.

 It is my humble opinion that the Maryland legislature has made an honest error that will have a profound impact on the device industry.  Maryland has two different applications for distribution licenses.  As authorized by state law, FDA licensed manufacturers can use the abbreviated form.  Wholesalers, on the other hand, are required to use the long form which adds the extra requirements of fingerprinting, the posting of a surety bond or other form of security, and depending on the state of residence, obtaining certification from the National Association of Boards of Pharmacy ("NABP") as a Verified Accredited Wholesale Distributor (“VAWD”), a lengthy and costly process.

 So where is the error you ask?  A device manufacturer, unlike a drug manufacturer,  must file the long form application, post surety and may be required to obtain VAWD certification before they can be properly licensed to distribute prescription medical devices into the State of Maryland.  How can this be?  I believe that it is merely an oversight by the drafters of the Maryland statute.  The Maryland Statute provides that “the information and qualification requirements for obtaining a permit under this subtitle, beyond that required by federal law, do not apply to a manufacturer who distributes its own prescription drugs.”  Md. Code Ann., tit. 10, subtit. 34, 22 § 12-6c-03.   As prescription devices are a separately defined term, the State Board of Pharmacy has determined that it can apply the relaxed requirements only to prescription drug manufacturers and not to prescription device manufacturers.

 There is no legitimate legislative or public policy purpose in holding an FDA registered device manufacturer to a higher standard than the manufacturer of prescription drugs.  As the state licensing laws are in place to ensure the integrity of the drug supply and prevent diversion and abuse, less stringent requirements are often imposed on device manufacturers.

 When confronted with such an apparent injustice there are two paths you can follow.  The first is to begrudgingly comply and lament the injustice that has befallen you.  The second is to try to right the wrong.  If you have a governmental affairs department, call them.  If you are a member of AdvaMed, call them.  If you work with outside lobbyists, call them.  If you have access to none of those resources, then call the Maryland Governor’s office.  The fix is simple.  The addition of three simple words “or prescription devices” will bring the statute in line with its obvious intent.  Take action.

Frank Fazio

Democrats Set Sights on Medical Device Safety Regulation

“Forewarned, forearmed; to be prepared is half the victory.” - Miguel de Cervantes

Ink-like clouds suffused over our nation’s capitol as a murder of crows converges upon fresh carrion. As the atramentous nebulae congealed over the Hill, the icy, soul-sucking breath of regulators chilled the device industry like Harry Potter’s tormenting dementors. Yes, my friends, Congress is coming and it has medical devices locked in the cross-hairs.

There is no subtlety as the portents blaze like neon along a moonless desert highway. In 2011 there were four congressional subcommittee hearings on the FDA’s regulation of medical devices. Unsatisfied with their colleagues on the other side of the aisle, Democrats, led by Henry Waxman (D-CA) as ranking member of the Committee on Energy and Commerce (“ the Committee”), have been advocating increased regulation of medical devices. In an October 12, 2011 letter to Fred Upton (R-MI), Chairman of the Committee, Joseph Pitts (R-PA), Chairman of the Subcommittee on Health, and Cliff Stearns (R-FL), Chairman of the Subcommittee on Oversight and Investigation, Waxman and colleagues Frank Pallone (D-NJ), Diana DeGette (D-CO) and John Dingell (D-MI) urged the Committee to hold hearings on device safety in conjunction with the impending reauthorization of the medical device user fee program. The letter detailed safety concerns with brain stents and metal-on-metal hip implants. Waxman et al. contended that the hearings held in 2011 focused on delays in approval and overregulation while ignoring serious health concerns. You can read the full text at http://democrats.energycommerce.house.gov/index.php?q=news/energy-and-commerce-democratic-leadership-calls-for-further-examination-of-fda-medical-device-r

A second letter was sent on January 20, 2012 by Waxman, DeGette, and Dingell renewing their prior request for hearings. This communication detailed concerns over the “Lap Band” gastric band and urogynecologic surgical mesh. The authors concluded by requesting the Committee hold hearings to determine “whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices” and urging the Committee to obtain documents in regard to the Lap Band and surgical mesh. Waxman again tied this review into the reauthorization of the Medical Device User Fee Act noting that “we [Congress] need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks.” Full text of letter at http://democrats.energycommerce.house.gov/index.php?q=news/democratic-committee-leaders-call-on-committee-republicans-to-hold-hearings-on-dangerous-medica

If you remain doubtful that Democrats are setting up device safety as an election year issue, then you likely missed President Obama’s State of the Union Address. Buried deep in the President’s remarks, it inconspicuously passed in a heartbeat. But it was there and worthy of repeating:

“We’ve all paid the price for lenders who sold mortgages to people who couldn’t afford them, and buyers who knew they couldn’t afford them. That’s why we need smart regulations to prevent irresponsible behavior. Rules to prevent financial fraud, or toxic dumping, or faulty medical devices, don’t destroy the free market. They make the free market work better.” President Barack Obama’s third state of the union address to Congress, January 24, 2012.

It was there. Just four days after Representative Waxman’s second letter to the Committee, the President slipped device safety regulation into the State of the Union. There can be no doubt that democrats are setting this up for an election year showdown. Although the President’s remarks are couched in terms of safety, Waxman specifically tied safety into marketing tactics. There is certainly evidence that impending regulation will not simply address safety in the approval process but will further impose stricter regulatory oversight of device marketing.

You have been forewarned. In the immortal words of Rubeus Hagrid, “It's changing out there. ... There's a storm coming, Harry. And we all best be ready when she does.”

Happy New Year! The FDA provides guidance on responding to “public” unsolicited requests for off-label information.

By: Frank Fazio

While the pharmaceutical and device industries are enjoying the Holiday break, the Food and Drug Administration (“FDA”) released a draft guidance for comment that will soon be published in the Federal Register.  The document, entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” (“Guidance”) provides much needed insight into FDA’s current thinking about those pesky “public” requests posted on web sites or in social media.

 The Guidance applies to unsolicited requests for information about unapproved uses of prescription drugs and biological products.  It also applies to medical devices marketed for a specific use without  product approval or clearance.  In regard to such devices, the FDA notes that a request for off-label information would include any use for which approval or clearance would be required.

 Through the use of various examples, the Guidance attempts to establish the boundary between solicited and unsolicited requests for off-label information.   Making that determination has always been the first step in deciding whether a response is appropriate.  The FDA concedes that internet and social media have provided new outlets whereby companies might be confronted with an unsolicited request for off-label information.  The Guidance classifies such requests as either non-public or public.  Non-public requests are those that are privately directed to the firm and are not visible to the public at large.  We all know what to do with those requests, although the Guidance reiterates and reaffirms the standard principles.  More interesting are the public requests.  The FDA defines these as “an unsolicited request in a public forum, whether directed to a firm specifically, or to a forum at large.”  The FDA notes that such requests can occur on company sponsored sites as well as on sites run by third-parties.  The FDA recognizes that it is in the interest of the public to permit the company to respond to such requests rather than relying on speculation and the misinformation that might be provided by other lay people on a thread.

 So how can the company respond in a compliant manner?  The FDA has determined that a response to a public request, whether on a company or third-party site, should be answered in a private manner.  The FDA cited concerns about the dissemination  of information to other individuals who did not make the unsolicited request as well as the enduring nature of a posted response.  The Guidance notes that a firm’s public response to a public request should clearly convey that the question pertains to an off-label use along with specific contact information for the medical or scientific personnel (e-mail, phone, etc.), so that the individual can follow up for additional information.  The individual providing such information must clearly disclose their involvement with the firm, and the response may not be promotional in any regard.  The public response should also include a direct link to the FDA approved labeling, but may not include links to any other information (e.g. firm or product websites, third-party websites, or other promotional materials).  Likewise, the URL for the labeling should not itself be promotional in any way.  By way of example, the Guidance notes that www.bestcancercure.com would not be an appropriate URL for the product label.  If the individual that made the public request then contacts the medical or scientific personnel, the request is then treated as any other non-public request.    

 The Guidance is well thought out and makes sense.  It permits firms to provide appropriate information in response to public requests without fear that such responses will lead to claims of off-label promotion.  The full text can be found at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145

Happy New Year!

A Holiday Present from CMS: Proposed Regulations Implementing Sunshine

More than 2 months after the October 1, 2011 deadline, the Centers for Medicare and Medicaid Services (CMS) has finally released the proposed rule that would implement the “Transparency Reports and Reporting of Physician Ownership or Investment Interests” section of the Patient Protection and Affordable Care Act (often referred to as the “Sunshine Act”).   The proposed rule would require manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program to report  payments or other transfers of value made to physicians and teaching hospitals.  It would also require manufacturers and group purchasing organizations (GPOs) to disclose physician ownership or investment interests.  Although the proposed rule is not scheduled to be published in the Federal Register until Monday, CMS issued a notice of proposed rulemaking yesterday and actually made available the unpublished rule.

So, what are the implications on timing for data collection and reporting?  In a lengthy preamble accompanying the draft rule, CMS is proposing that manufacturers and GPOs would not be required  to begin collecting data for federal disclosure on January 1, 2012, but that they will be able to wait until the final regulations are issued sometime in 2012.  As a result, manufacturers and GPOs would submit a disclosure report for only part of 2012 on March 31, 2013.  CMS will then aggregate these submissions and provide physicians and teaching hospitals 45 days to review the information before it is made publicly available by September 30, 2013.  Applicable manufacturers and other interested parties will have until 5 pm Eastern Standard Time on February 17, 2012, to submit their comments on the proposed rule electronically; by regular, express or overnight mail; or by hand or courier. 

Many in industry have been working frantically to meet the January 1, 2012 deadline to begin data collection, and perhaps some companies will forge ahead as planned and begin collecting, and perhaps voluntarily reporting their spend as of January 1.   For others, the proposed delay  may be a welcome reprieve and an opportunity to prepare for compliance, now with the added benefit of the proposed rule.  Either way, Happy Holidays!