Life Science Compliance Update

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38 posts from May 2014

May 30, 2014

Connecticut Transparency Law: APRN Payment Reporting Date Pushed Back to July 1, 2015

We recently covered a new Connecticut law that requires pharmaceutical and device companies to report payments made to advance practice registered nurses (APRNs). The recently passed House Bill No. 5597 pushed back the start date of the reporting process. The revised bill makes the payments made to APRNs reportable after July 1, 2015, instead of January 1, 2015. It also allows the commissioner of the Department of Consumer Protection, instead of the Department of Public Health, to publish the information on his department's website. The bill was passed by both houses and signed by the governor.

"An Act Implementing Provisions of the State Budget for the Fiscal Year Ending June 30, 2015," was introduced by Representative J. Brendan Sharkey, 88th District and Senator Donald E. Williams, 29th District. The new section 75 can be read independently or with other provisions here. Section 75, about one-third of the way through is the provision for nurse practitioner reporting.

§ 75: MANUFACTURERS' DISCLOSURE REQUIREMENTS FOR PAYMENTS TO APRN's

(b) (1) Not later than [January] July 1, 2015, and quarterly thereafter, an applicable manufacturer that provides a payment or other transfer of value to an advanced practice registered nurse, who is practicing in the state, shall submit to the Commissioner of [Public Health] Consumer Protection, in the form and manner prescribed by the commissioner, the information described in 42 USC 1320a-7h, as amended from time to time.

(2) The commissioner may publish such information on the Department of [Public Health's] Consumer Protection's Internet web site.

(c) An applicable manufacturer that fails to report in accordance with this section shall be assessed a civil penalty in an amount not less than one thousand dollars or more than four thousand dollars for each payment or other transfer of value not reported.

Unchanged by the bill, the law applies to manufacturers of drugs, devices, biologicals, or medical supplies that are covered by (1) Medicare or (2) the state Medicaid or Children's Health Insurance Program plan, including a plan waiver. The law does not apply to transfers made indirectly to an APRN through a third party, in connection with an activity or service in which the manufacturer is unaware of the APRN's identity.

Discussion

We noted in our previous article that Connecticut's law is unique for a number of reasons. This is the first time that any state has required reporting only on APRNs, and that a state has mandated quarterly reporting with no minimum payment and no meaningful exemptions.

Moving the reporting date 6 months down the road seems like a sign that this provision was not fully developed. We were the first to cover the law on May 19th because there was no mention of debate on the payment disclosure issue in the legislative hearings. According to the committee records, the debate focused solely on whether or not to allow APRN's to operate independently. The disclosure provision is so vague that it appears tacked on the end of the APRN-independence law as an afterthought, with little focus being spent on the logistics and resources involved in the extensive reporting. 

As we previously discussed that payments to APRN's reprensents less than 1% of the total payments to healthcare providers in Massachussetts and Vermont which have state reporting.  It is unclear the actual need for such a law but time will tell.

ASCO Not Enforcing Pharmaceutical and Device Speaker Ban in 2014

This weekend opens the largest oncology meeting in the world ASCO 2014 in Chicago, IL. Over 20,000 oncologists from around the world come to hear the latest science in cancer treatment including presentations by company scientists on preclinical, phase I and phase II treatments.

Last year the American Society of Clinical Oncology (ASCO), drastically changed their policy on how they deal with perceived conflicts of interest. The policy stated that ASCO would not accept research abstracts or manuscripts by authors who had been an employee, major stockholder, or member of the speakers' bureau of the sponsor of the research during the past two years. We noted that this policy would further shrink US conference attendance.

Just recently, however, ASCO announced that they would delay enforcement of the speaker ban until it could assess the full impact that the restrictions on relationships with companies would have on research publication and presentation with respect to ASCO's educational and scientific offerings as well as the authors. "The author restrictions set out in Section V [the speaker ban] will not be enforced, pending a two-to-three-year period of data-gathering and analysis," ASCO notes.

We believe the speaker ban is an unworkable policy, and this delay shows hopefully that ASCO recognizes it as well. American associations who have adopted similar policies have seen 30 – 40% reductions in attendance for US meetings. European counterparts, on the other hand, have exploded with corresponding increases in attendance. While this would be fine if US patients could benefit from education overseas, the reality is that medical studies presented and published in Europe can take years before US physicians hear about them. In field like oncology, where patients need cutting edge treatment, this is a real problem.

While ASCO delayed the enforcement on the two year outright ban, they adopted new disclosure requirements that are strict. The new policy names eight categories of financial relationships that must be disclosed: (1) compensated employment, (2) leadership positions, (3) consulting activities, (4) speaking engagements, (5) expert testimony, (6) ownership interests, (7) research funding, and (8) patents or other intellectual property interests.

Furthermore, all authors, including the first, last, and corresponding authors, will be required to fully disclose all of their financial relationships with for-profit health care companies, regardless of whether the author believes the relationships to be specifically relevant to their research or ASCO activity. The first, last, and corresponding authors are required to answer additional non-restrictive questions regarding their relationships with the research sponsor for reports on original research.

It will be interesting to see whether ASCO eventually bans speakers or whether the "two-to-three-year period of data-gathering and analysis" changes their minds.

We also wonder what the effect of the original announcement had on the quality and quantity of abstracts submitted to their meeting. I think the "gathering of information" will show them banning company science was a very bad idea to begin with.

May 29, 2014

FDA Draft Guidance: Best Practices in Developing Proprietary Drug Names

Medication errors account for an estimated 7,000 deaths annually, according to a 1999 Institute of Medicine (IOM) report. IOM followed this up in 2006 with a report that found major problems with naming, labeling, and packaging that resulted in patient harm. Today, FDA issued a Draft Guidance to help sponsors of pharmaceutical and biological products develop proprietary names that do not cause or contribute to medication errors or otherwise contribute to the misbranding of the drug. Comments regarding the draft must be submitted by July 28, 2014.

The concept behind this draft guidance is simple: It is important for safety reasons that the written proprietary name not look like that of another proprietary name nor sound like another proprietary name when spoken. Similarity between the proprietary name of a new prescription drug and the proprietary name of an existing drug could cause a mix-up in ordering and a patient could receive one drug instead of the other. 

Below is a summary of the sixteen areas in which FDA offers screening recommendations. Often these are for "readily identifiable reasons." See page 4 of the Draft Guidance for more specifics regarding each recommendation.

  1. Obvious Similarities in Spelling and Pronunciation of Proprietary Names: Proprietary names should not be similar in spelling or pronunciation to proprietary names, established names, or ingredients of other products. FDA recommends sponsors conduct a preliminary screening to eliminate names with obvious similarities to the names of existing products known to the sponsor.

  2. Medical Abbreviations: Proprietary names should not incorporate medical abbreviations (e.g., QD, BID) because the incorporation of such abbreviations could inadvertently be a source of error. Sponsors should avoid using potentially confusing abbreviations and symbols found in the Joint Commissions "Do Not Use" list.

  3. Inert or Inactive Ingredients: Proprietary names should not incorporate any reference to inactive ingredients in a way that overstates the inactive's actual role in the drug.

  4. Combinations of Active Ingredients: Proprietary names of fixed combination drug products should not include or suggest the name of one or more, but not all, of its active ingredients. 

  5. United States Adopted Name (USAN) Stems: Sponsors should screen proposed proprietary names against the stem list created by the USAN Council to ensure a stem is not present in the stem position in the proprietary name.

  6. Same Proprietary Name for Products Containing Different Active Ingredients: Sponsors should not use the same proprietary name or the same root proprietary name for products that do not contain at least one common active ingredient contained in the original marketed product. When two or more products have the same name and do not share any active ingredients in common with the original marketed product, patients could be confused about the products' ingredients and how each product should be used. In some cases, the name has led to the use of products at the wrong dose, for the wrong indication, or in the wrong patient population. Such name confusion errors have resulted in serious adverse reactions when patients were medicated in error with an active ingredient that was not intended to be administered.

  7. Reuse of Proprietary Names: Sponsors should not reuse the proprietary name of a discontinued product when marketing a different drug or biological product because there is a strong risk that users may continue to associate the name with the original discontinued product.

  8. Names that include reference to product-specific attributes: FDA recommends that sponsors avoid incorporating product-specific attributes, such as manufacturing characteristics (e.g. "NameLyophylized"), dosage form (e.g. "Nametabs") or route of administration (e.g. "Nameoral"), as part of the proposed proprietary name. Including references to product-specific attributes in the root proprietary name may be acceptable if the product-specific attribute is consistent with the terminology used in the product's labeling and does not pose additional risks for medication error. However, in developing the names that include or make reference to product-specific attributes, companies may wish to consider that future changes in dosage form or route of administration or manufacturing characteristics may render the original proprietary name inaccurate.

  9. Dosing Interval: FDA generally discourage sponsors from adopting proprietary names that refer to product dosing interval, such as "NameQD" or "NameBID," even when the name accurately reflects the product's dosing instructions. This information is subject to change during the course of application review and during marketing if the approval of new dosing intervals, formulations, indications, or use in different patient populations causes the original proprietary name to then be misleading.

  10. Modifiers as Components of a Proprietary Name: Some proprietary names are constructed of a root proprietary name modified by added words or components, which are referred to as modifiers. FDA notes that inconsistent use of modifiers and the absence of a standardized meaning for such terms can be confusing to end users. Misinterpretation of the intended meaning of the modifier has led to medication errors, such as dispensing and administering the wrong drug, wrong formulation, wrong dose, wrong strength, or wrong frequency of administration. Medication errors have also occurred within the same product line if the distinguishing modifier is omitted or disregarded when a product is prescribed. FDA includes a long list of questions and specifics regarding modifiers (page 8 of the Draft).
     
  11. Brand Name Extensions: Each request for review of a proposed proprietary brand name extension will be evaluated to consider whether the products share at least one common active ingredient, the products are differentiated by labeling (carton and container), the modifiers used are appropriate and effectively differentiate the product among members of the same product line. FDA notes that brand name extenders have posed problems when the same root proprietary name is used for multiple products without modifiers that adequately differentiate among the products.
     
  12. Dual Proprietary Names: Using distinct proprietary names for products that contain the identical active ingredient(s) but have different indications of use could pose potential safety risks, for example, if practitioners are unaware that two products prescribed for concomitant use contain the same active ingredient. This could lead to overdose or dose-related adverse reactions. Another risk may be if a drug-drug interaction is not noted because the healthcare professional and patient are unaware that a product sold under a proprietary name contains the same drug as another product with a different proprietary name.
     
  13. Proprietary Names of Drug Products Marketed Outside the US: Medication errors resulting in dispensing and administration of the wrong drug have occurred when a proprietary name for a product marketed in the US is identical, or virtually identical in spelling and pronunciation, to a foreign product containing an entirely different active ingredient marketed in a foreign country.
     
  14. Prescription to Over-the-Counter Status: FDA notes that continued use of the original proprietary name might be appropriate when there is a full switch (i.e., all indications, dosing, and strengths previously limited to prescription use will now all be available OTC). However, when the product switch is only partial (i.e., prescription-only status still applies to some indications, dosages, or strengths), it might be appropriate to market the OTC product under a different or modified proprietary name.https://www.federalregister.gov/articles/2014/05/29/2014-12348/best-practices-in-developing-proprietary-names-for-drugs-draft-guidance-for-industry
     
  15. Use of Symbols: FDA discourages sponsors from using symbols (i.e., "+" or "&") to link components in proprietary names because symbols can be misinterpreted or confusing (e.g., "+" can be read as "4").

  16. Incorporation of the Sponsor's Name: Proprietary names should not incorporate the sponsor's name across multiple products (e.g., "ABCName1," "ABCName2," "ABCName3"). This practice can result in creating multiple similar proprietary names, which might increase the risk of confusion among the products. The practice can also be problematic when products are stored alphabetically in distributor or pharmacy locations or when products are ordered from alphabetized lists.

FDA offered a helpful flowchart for companies to use as an "Overview of Considerations for Evaluating a Proposed Proprietary Name":

Comments and suggestions regarding the FDA draft should be submitted by July 29, 2014. Submit electronic comments to http://www.regulations.gov/

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

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