PPTA Letter to Stakeholders re: North America Data Program

Dear PPTA Stakeholders,

PPTA's North America data program was established in 1998 in response to a specific recommendation of the Advisory Committee on Blood Safety and Availability (ACBSA).

Since its inception, the program has served as a highly effective shortage preparedness/response mechanism by providing stakeholders – including regulators, patient advocacy groups, physicians, and hospitals – with important public health information regarding the U.S. supply of immune globulin, albumin, and factor VIII products. I write to you now to confirm PPTA's ongoing commitment to the data program, as well as to inform you of some upcoming changes.

As you know, drug shortages are once again in the news though, thankfully, there have been no recent shortages of plasma protein therapies. The Food and Drug Administration (FDA) held a public workshop on drug shortages in September, and has recently released a report and recommendations. Draft legislation on drug shortages – known as the Preserving Access to Life-Saving Medications Act – is circulating in both houses of Congress. Most recently – on October 31, 2011 – President Obama issued an Executive Order on drug shortages, which directs FDA to enforce existing reporting requirements and to encourage broader, voluntary reporting of potential shortage-related information by manufacturers. As leaders in the area of shortage preparedness, PPTA and the plasma protein therapies industry applaud these efforts.

PPTA is also pleased to report that the Association's North America data program will once again encompass all major manufacturers of plasma protein therapies that supply the U.S. market. To accomplish this, PPTA is implementing a few modifications to the data program, the most notable of which is the move from a one-month reporting lag to a three-month reporting lag. In practice this will mean, for example, that product supply data reported by participating manufacturers in October 2011 will be reported, in aggregate form, on PPTA’s Web site in early February 2012. This change is effective immediately.

PPTA has not implemented this change lightly. The 1998 ACBSA recommendation specifically calls for "monthly" reporting. However, the move to a three-month reporting lag was deemed necessary in order to achieve the broadest possible industry participation in the data program. The change is accompanied by important safeguards including, most notably, that in the event of an actual shortage – as determined by FDA, the Department of Health and Human Services, ACBSA, or the Blood Products Advisory Committee – PPTA has the ability to return to monthly, or even more frequent, data reporting if deemed necessary.

As stated at the outset, PPTA's commitment to shortage preparedness-related supply data reporting remains firm. We believe these changes will make the North America data program even stronger and more useful to stakeholders. If you have any questions regarding the changes, or would like to discuss further, please do not hesitate to contact Association staff.

Sincerely,

Julie A. Birkofer
Senior Vice President
PPTA North America

[1]ACBSA, Blood Safety Recommendations – April 1998 (May 8, 1998), available at http://www.hhs.gov/ophs/bloodsafety/advisorycommittee/recommendations/resapr98.html.

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