Pharmaspective

The Razor’s Edge: Clinical Trial Results Reporting or Illegal Promotion?

 Peruse the web site of any branded pharmaceutical or biotech company and you will likely find a section describing its pipeline.  That section often summarizes investigational products, where they are in the developmental process, and provides summary results of the latest clinical trials.  Communicating such information has value to both the scientific community as well as potential investors attempting to divine the company’s financial direction.  

 The federal regulations permit a company to engage in a full exchange of scientific information “including dissemination of scientific findings in scientific or lay media.”  21 CFR §312.7(a).  A company is not, however, permitted to represent “in a promotional context that an investigational new drug is safe or  effective for the purposes for which it is under investigation.”  But when does a company cross the razor’s edge from factual communication to illegal promotion?   

 On June 30, 2011, the Division of Drug Marketing, Advertising, and Communications (DDMAC) issued an untitled letter to AOI Pharmaceuticals, Inc./Keryx Biopharmaceuticals, Inc. (“Keryx”) for crossing that line on its web site.  DDMAC found that several of the comments in the “About Us” and “Product Pipeline” sections of the Keryx web site were “promotional,”  contravening  the federal regulation. 

 The offending claims identified by DDMAC could likely be found on dozens of other web sites.  They included a representation that the compound “has demonstrated both safety and clinical efficacy.”  They also reported that the  “safety profile is distinctly different from that of most cytotoxic agents” and it “does not appear to cause” certain side effects common among the class.  The web site summary further claimed that the trials “demonstrated that [the product] can be safely given to humans with a manageable toxicity profile” and “has been well tolerated …”   A casual review of the offending website would lead one to believe that Keryx was attempting to couch these claims as clinical findings.  They used words and phrases such as “demonstrated” and “does not appear” in an attempt to walk the line between communication and promotion.

  Keryx also included standard disclaimer language stating that “This investigational drug product has not been approved by the US Food and Drug Administration for safety and effectiveness.  This investigational drug product is still undergoing clinical study to verify its safety and effectiveness.”  DDMAC determined that this disclaimer was insufficient “to mitigate the overwhelming misleading impression conveyed by claims on Keryx’s website.”

 So how do you report on pipeline status and positive clinical trial results without crossing the line into illegal promotion?  Keryx may have been able to avoid this untitled letter by more clearly noting that clinical trials to date had provided encouraging data on safety and efficacy while noting that additional research is required.  Will your web site pass muster? Although there is no certainty, a working knowledge of untitled and warning letters will provide valuable guidance in ensuring your company’s promotional compliance.

Legislators in Maine and Massachusetts Make Noise About Disclosure and Gift Ban Laws

 
In a prior post, “Vermont Marketing Disclosure Reports Move from Fiscal Year to Calendar Year,” we queried whether any state would amend their marketing disclosure laws to allow the federal  law to completely preempt the state requirements.  While we have not seen any state legislature pass a bill to repeal its disclosure laws and rely solely on the federal laws, a number of state legislators are finally making much needed noise in opposition of their state-specific disclosure and gift ban laws.  Specifically, in Massachusetts, House Speaker Robert DeLeo (D) recently went on record to voice his opposition to Massachusetts ban on gifts and meals from pharmaceutical companies to doctors.  In Representative DeLeo’s opinion, the gift and meal ban is a “hindrance” to job creation and deters companies from doing business in Massachusetts.  Additionally, in Maine, Republican legislators presented Maine bill LD 719 to repeal certain state disclosure requirements, which the Governor of Maine signed into law today.  Maine’s bill LD 719 goes into effect September 28, 2011 and will repeal specific sections of Maine’s Revised Statutes that currently require manufacturers and labelers of prescription drugs to annually disclose certain expenses related to marketing.  LD 719 will also repeal other sections of the Maine’s law that require the disclosure of the average manufacturer price and best price of certain drugs and the disclosure of clinical trials on prescription drugs on a publicly accessible website.  The sponsor of this bill, Representative Meredith Strang Burgess, stated that “the general theme this session is to stop making Maine more difficult than other states [for business].  We certainly want to make sure we’re being smart [about regulation], but at the same time not going too far and letting the free market prevail.” 

Are these marketing disclosure laws and/or gift and meal bans putting these states at a competitive disadvantage?  What if life science companies choose to limit (or even stop) their sales and marketing activities in the more burdensome states?  Detailing and related sales activities, which often occur in conjunction with a meal, provide healthcare professionals with valuable information regarding new medications and can serve to improve patient care.  By discouraging or forbidding these activities, the general public may not have the most current information regarding advances in treatment options.  While I agree that the government should regulate and discourage bad behavior, it appears that some state regulations may have crossed the line from smart, effective regulation to burdensome, over-regulation. 

The common theme of legislators’ oppositions to disclosure and gift ban laws is job creation.  Other legislators that remain steadfast in their support of such laws continue to defend those laws as being important and effective in driving down drug costs.  Will this position be weakened once the data disclosed to the federal government is made available to all state governments?  How will states justify more stringent state-specific requirements when other states are gaining the benefit of the federal disclosure data without the burden and cost of having a state-specific disclosure law?