Juvan's Health Law & Private Equity Report : Corporate & Health Care Lawyer & Attorney : Jayne Juvan : Benesch Friedlander Law Firm : Private Equity, Corporate Governance

As many of my readers know, particularly including those who are lawyers, tracking pending legislation affecting the pharmaceutical and medical device industries on both a state by state and federal basis can be an especially daunting task.  Obviously, these industries are highly regulated, and as each new issue presents itself, the federal and state legislatures do what they do best:  legislate some more!  The result is a highly complex, almost rainbow-like color scheme of regulations that are often inconsistent, contradictory and sometimes, well, nonsensical (my apologies in advance to the decision makers).

With the help of Matthew Samsa, a summer associate at Benesch, I have located a fabulous tracking source that I can't help but share.  I'd suggest that you check out the 2007 Prescription Drug State Legislation tracker, hosted by the National Conference of State Legislatures, which is the "Forum of America's Ideas."  So, for example, what does Colorado have to say about pedigree legislation?  According to the site, legislation was just passed that "[w]ould regulate prescription drug wholesalers; including requiring criminal history background checks of applicant representatives, updating requirement for maintaining and retaining "pedigree" records to prevent or diversion to unauthorized buyers." The site further mentions the following status information:  "Filed 3/6/07; passed Senate 4/2/07; passed House 4/12/07; amended and sent to governor 5/15/07."

Of course, I can't make any representations or warranties about the accuracy of the content and how often the site is updated (if only I could write without including a disclaimer).  I can say, however, that this site may make tracking state legislation affecting the pharmaceutical industry a far more manageable task.  If you're at all like me, you probably feel like a kid in a candy store right now.  Enjoy!

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But interested in knowing the candidates' views on health care?

The Kaiser Family Foundation has offered snippets of the CNN debates that highlight the candidates views on health care.  Check them out!

CNN 2008 Democratic Debate Excerpts

CNN 2008 Republican Debate Excerpts

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"Unauthorized" or "secondary" wholesalers have continued to demonstrate their commitment to overcoming federal pedigree laws that impose an obligation on them to track the chain of custody of drugs back to the manufacturer.  An organized group of these parties recently filed an amicus curiae brief with the United States Court of Appeals for the Second Circuit, arguing that the law violates the United States Constitution for failing to place the same pedigree requirements on authorized distributors, or those distributors that have entered into distribution agreements with manufacturers.  The brief argues that the law would, in effect, put these companies out of business because compliance would be impossible. 

The National Coalition of Pharmaceutical Distributors, Inc. filed the brief.  Without going into too many of the legal arguments set forth therein, essentially, the brief elaborates on several of the points made in the plaintiffs' filings to date and argues that the injunction put into place by the district court that has temporarily prohibited the enforcement of the implementing regulations ought to remain in effect. 

For those readers who are unfamilar,  "amicus curiae"  is a latin phrase that means "friend of the court."   An amicus curiae brief allows a person who is not a party to a case to file a document that provides additional information on a point of law a court is considering in attempt to provide guidance.  Academics also may file treatises with a court that present an academic discussion.

While these secondary wholesalers have refused to back down, many supporting the "big three" authorized distributors have consistently argued that the secondary market poses the greatest risk to the safety of the supply chain and therefore ought to be subject to the most stringent requirements.     

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In an effort to better inform the public about drug and patient safety information, PhRMA has launched new web site pages.   In its press release about the new web pages, PhRMA states as follows:

• Patient safety is our highest priority. We need a strong and effective FDA with the resources and personnel necessary to ensure the safety of the U.S. drug supply and continued access to innovative medicines.
• Patient welfare should be at the center of any effort to enhance drug safety and ensure that benefit and risk are balanced.
• Drug safety and effectiveness monitoring must be comprehensive and continuous. PhRMA supports efforts that seek to continually improve these activities.
• Patients and health care providers must have accurate, timely, and useful information on which to base their decisions.  

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In attempt to more logically catalog posts, articles will no longer be posted under the heading "Juvan's Health Law Recap."  Nevertheless, this blog will continue to track legal developments affecting the health care industry on a weekly basis.

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