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Bring drug labeling into the 21st century

We all know the tale of progress and the efforts of economic Luddites to retard technological usage and innovation.  New forms of technology upset the economic apple cart and those a step behind try to hinder progress.  And, the latest story involves an entirely sensible proposal to permit drug companies to provide important drug safety information through the Internet.

On May 18, 2015, the Food and Drug Administration (FDA) concluded the public comment period on the proposed rule FDA-2007-N-0363, or the “electronic distribution of prescribing information for human prescription drugs, including biological products.”  The rule aims to update the current regulatory system which still requires drug manufacturers to provide drug prescribing information in the form of dual-sided, small-print paper package inserts for all prescription drugs ordered by healthcare professionals.  Since these documents are like old-fashioned roadmaps in 6 or 8-point font, they are unwieldy and extraordinarily difficult to decipher.  Not surprisingly, the main opponent of bringing drug labeling into the 21st century is the Pharmaceutical Printed Literature Association (PPLA), the association representing the manufacturers of all paper packaging for pharmaceuticals in the United States.   

{mosads}The FDA has proposed to modernize the current drug information system by creating an electronic labeling or “e-labeling” system populated by the drug manufacturer and designed to offer healthcare providers with the most up-to-date prescribing information possible.  The proposed rule is the first step in the FDA requiring manufacturers move all drug labeling online, including medication guides and patient package inserts. 

Some, including the PPLA, have criticized this common sense regulation offered by the FDA.  In particular, some have suggested that the shift from paper forms to e-labeling could be difficult for some healthcare providers.  Others argue that the rule unduly burdens pharmacists who lack access to the internet, instead suggesting that a “dual system,” using both paper forms and e-labeling, should be implemented.  Lastly, some opponents to the proposed rule have gone as far as to argue that electronic system would not be able to withstand a public health emergency or natural disaster.

None of these arguments are worth the paper they are printed on.

These thin arguments attempt to require paper notice forms that are so complex and miniscule to be meaningful.  Simply, the critics concerns are overblown.  First, like all modern businesses, the vast majority of healthcare providers have access and use the internet for business related transactions.  As noted by the FDA in the proposed rule, only six percent of pharmacies use the current paper forms for prescribing information with most providers instead relying on other sources including online information.  The e-labeling system proposed by the FDA would be more intuitive than the current paper forms allowing providers to use search functions to find vital health information instead of sifting through small-print paper.  Still, in recognition that a minimal number of healthcare providers have limited to no internet access, the proposed FDA rule has instituted a hardship exemption, a 24/7 hotline for prescribing information maintained and operated by the drug manufacturer.

The proffered dual system of both paper and e-labels is not a suitable alternative.  Over the course of a drug’s time in the marketplace, a manufacturer will often update or change the drug’s prescribing information.  Given the changing nature of prescribing information, having two different sources could lead to significant confusion among healthcare providers and potential health problems for patients. Pharmacists and other healthcare providers utilizing the old paper forms could be relying on outdated and incorrect information.  Reliance on the outdated information could result in a prescribing error by the healthcare provider.  By switching strictly to e-labeling, providers will always have the most current information.

Lastly, a hypothetical natural disaster or public health emergency offers no reason to not modernizing the drug labeling system.  Similar statements were made when hospitals and physicians switched to electronic healthcare records (EHR).  Yet, EHR systems, like those implemented by hospitals in Joplin, Missouri prior to the 2011 tornado that devastated the small town, are crucial in tracking a patient’s healthcare records when paper records are destroyed or misplaced by an emergency.  

Finally, switching to electronic notice will provide substantial cost savings.  Last year, Americans filled four billion prescriptions at pharmacies across the country.  These prescriptions contained the complex, dual-sided and small font paper forms with each drug’s prescribing information.  The FDA estimates that switching to e-labeling for prescribing information will produce annualized savings of nearly $74 million.

Consumers and healthcare providers should applaud the proposed system and not surprisingly major consumer groups including Consumer Watchdog and US PIRG filed a comment supporting the reforms.  Patients and healthcare providers will have greater access to information leading to lower risk of drug complications from drug-to-drug interactions.  Moreover, improved access and current information will lead to better clinical decisions, prevent potential health problems, and improve patients’ overall health.  

Balto, an attorney, is a senior fellow at the Center for American Progress and former policy director at the Federal Trade Commission. Kovacs is an attorney with Balto’s law firm with a concentration on healthcare issues.


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