Pharmaspective

AdvaMed, PhRMA and Other Industry Organizations Encourage CMS to “Promptly Publish” the Final Rule Implementing the Sunshine Act

On August 14, 2012, several industry organizations, including the Advanced Medical Technology Association (AdvaMed) and the Pharmaceutical Research and Manufacturers of America (PhRMA), sent a joint letter to Marilyn Travenner, Acting Administrator at the Centers for Medicare and Medicaid Services (CMS), encouraging CMS to “promptly publish” the final rule implementing the Sunshine Act provisions of the Patient Protection and Affordable Care Act. In addition, the organizations request that CMS provide applicable manufacturers 180 days after the final rule is published before requiring data collection. The organizations believe that its member companies will need this additional time to “properly implement the data collection and reporting required by the Sunshine provisions,” as well as time for “system development, implementation, testing, and training.”

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