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HCPC Urges FDA to Reconsider Ban on Calendarized Generics that Differ from Branded Drugs

October 15, 2009 – 5:29 pm

The Healthcare Compliance Packaging Council sent the following letter to FDA, HHS, and the White House today. Executive director Peter Mayberry wrote to protest an FDA decision that “prohibits generic drug manufacturers from calendarizing unit dose blister cards, strips, and other packaging formats” if the branded drug was not packaged and labeled in those formats.

Given the persistent difficulty patients have with following drug regimens, I hope that FDA won’t stop the use of innovation just because labeling formats differ between brand and generic drugs. Generic drug makers (and branded, too) have made investments in tackling the issue with packaging solutions, so as long as the labeling content is the same, why not let packaging innovations go forward?

Or should the agency instead suggest that branded drugs address noncompliance from the very beginning, with packaging and labeling solutions that offer some means of patient support?

We’d love to hear your thoughts!

Daphne Allen

Attachment:

October 15, 2009

Via Facsimile: 202/456-2461

Nancy-Ann Min Deparle
Counselor to the President and
Director of the White House Office of
Health Reform
1600 Pennsylvania Avenue, NW
Washington, DC 20500

Dear Ms. Deparle:

Following up on contact with your office earlier this year, I am writing on behalf of the Healthcare Compliance Packaging Council (HCPC) regarding an urgent matter which has just come to my attention. Specifically, I have been in contact with the Labeling and Program Support Division of the U.S. Food & Drug Administration’s Office of Generic Drugs regarding a decision that was made on consult with FDA’s Office of Drug Safety that prohibits generic drug manufacturers from “calendarizing” unit dose blister cards, strips, and other packaging formats.

As it has been explained to me, this decision is predicated on the long-standing determination within OGD that labeling for generic products must be consistent with approved labeling for “branded” versions of the same drug. Therefore, if the original manufacturer did not submit calendarized labeling as part of their new drug application – or did not seek a change to their NDA at some point after the product’s approval – then it should not be permissible for a generic manufacturer to obtain a change in labeling that allows them to add this important compliance-prompting feature once the product has gone off patent.

During a meeting with your staff on July 21, 2009, members of the HCPC Board of Directors and I presented an overview of the huge problems associated with pharmaceutical non-compliance in the United States (i.e., people not taking their medications properly) as well as the proven role that calendarized unit dose packaging can play in reducing non-adherence to prescription drug regimens. We also noted that an estimated 30-40 percent of all documented incidents of non-compliance are related to factors such as forgetfulness and uncertainty as to whether a dose has been taken.

In addition, we presented peer-reviewed, published data demonstrating that research subjects achieved far greater rates of adherence when their prescription medications were given to them in calendarized blister packs instead of pharmacy vials. Lastly, we offered economic data on the scope of the non-compliance problem and estimates that improving adherence nationwide by a mere 10 percent could provide annual savings of at least $20 billion to our national economy.

Virtually everything we discussed with your staff on July 21 was backed up by documentation which we provided on September 11, 2009.

I am writing, therefore, to seek your intervention in this issue. Specifically, I am hopeful that the Obama Administration will consider this matter carefully and seek a remedy by which manufacturers of generic drugs may, voluntarily, if they choose to do so, and with FDA’s approval, add calendarizing label features to products which they elect to package in unit dose formats. Such action on your part would help to improve healthcare outcomes, reduce healthcare spending, and would not change any of the prescribing language set forth by the original manufacturer.

Please feel free to contact me directly should you have any questions or require any additional information regarding this request, and I thank you for your consideration.

Sincerely,

Peter G. Mayberry
Executive Director

cc: Kathleen Sebelius, Secretary, U.S. Department of Health and Human Services
Margaret Hamburg, M.D., Commissioner, U.S. Food and Drug Administration

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