The Food and Drug Administration is going back at the patient insert industry (PI industry) that mainly involves pharmacists and other drug professionals. The newest proposal will require the elimination of the paper insert in lieu of putting it all on the internet. This does not include those areas where the patient/consumer receives the PI directly.
“The Food and Drug Administration (FDA or the Agency) is proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professional, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed.” FDA is also proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed except at provided by regulation. ” FDA-2007-N-0363
This proposal is pointed at those companies that manufacture PI’s which are often glued to the top of large bottles of medication. The “bulk” materials are often repackaged in smaller containers to be given to patients/consumers. (This is only about 4% of JH Bertrand’s business, but it is a very interesting story to us) The proposal is to require this information to be online only and to forbid it from being on the product package.
A year ago, this idea was part of a bill that was moving through the US Senate and House of Representatives. A few senators removed it from the bill (H.R.1919- Safeguarding America’s Pharmaceuticals Act of 2013) and the PI industry breathed a sigh of relief. Now, the FDA is back at it again.
PPLA which represents the manufacturers of patient inserts and a US senator ( Susan M. Collins) have written the FDA in protest of this proposed rule. They argue that shaky networks, power outages and rural locations will put patients and medical personal at risk. Furthermore, they argue that during natural disasters there may be no access to the internet. And, many communities around the country still have limited internet access. You can see that they have a point as power seems to be less consistent than it used to be. And, of course, every other day we are hearing about major computer system being hacked ie Sony Pictures being the latest creating huge issues for all involved.
Paper is bulletproof. It’s doesn’t need a computer or phone to be powered up to read it. It can’t be hacked. Paper is the best back up system that exists! Everybody can use it; All you need to do is be able to read.
Conversely, the FDA argues that professionals have wide access to the internet and that the patient information in paper form is wasteful and unnecessary.
Certainly, JH Bertrand is on the side of the PI manufacturers as paper backup is being proven over and over again to be a smart move for all involved. We hope the FDA will drop this proposal and follow what Congress debated and decided last year.
The location of the FDA document is http://federalregister.gov/a/2014-29522