The retail pharmacy trade associations are urging the House leadership to delete language creating an adverse event reporting hotline from the pediatric exclusivity bill.

In an Oct. 24 letter to Energy & Commerce Chairman Billy Tauzin (R-La.), five pharmacy associations urged "that this provision be removed from any final bill, and that Congress works with the health professional community to find ways to enhance reporting of ADEs without compromising patient care."

The letter is signed by the American Pharmaceutical Association, the American Society of Consultant Pharmacists, the National Association of Boards of Pharmacy, the National Association of Chain Drug Stores and the National Community Pharmacists Association.

The provision was included in "The Best Pharmaceuticals for Children Act" (HR 2887) at the urging of Rep. Bart Stupak (D-Mich.). The bill directs HHS to promulgate a regulation to create a toll-free number for consumers to report adverse events from medications directly to FDA. Stupak's interest in adverse event reporting follows from hearings on the side effects of Accutane (see ¹ Also see "Roche Accutane Prescriber Registry Added To Pregnancy Prevention Program" - Pink Sheet, 5 November, 2001. ).

"We believe that including this information on the label may, in fact, have a negative impact on patient care," the pharmacy groups said. The letter argues that the prescription bottle is already too crowded with the main label and auxiliary labels. "Pharmacists should not be placed in a position of questioning their professional judgment in deciding which labels to affix in order to accommodate a mandated FDA number on the label," the letter says.

The pharmacy groups suggest that patients will become confused about when to call the 800 number, and FDA may be flooded with calls intended for the pharmacist or physician.

Finally, the letter adds, "the determination of the contents of a prescription label is the purview of the state board of pharmacy, not FDA."

The House may begin debate on the pediatric bill as early as the week of Nov. 5. The leadership is understood to be seeking consideration of the bill under suspension procedures that prohibit amendments.

However, the toll-free number provision is one of several issues where consensus has not been reached.

Rep. Stupak is still seeking language in the bill that would tie the grant of exclusivity to labeling changes, rather than the submission of studies. The committee version of the bill establishes a dispute resolution procedure to encourage manufacturers and FDA to expedite pediatric labeling discussions.

Stupak's amendment was defeated in markup, but the committee leadership promised to work with him on a compromise before the bill comes to the floor (² Also see "Pediatric Labeling Would Not Block Generic Approval - House Exclusivity Bill" - Pink Sheet, 15 October, 2001., p. 8).

In an Oct. 31 floor statement, Stupak indicated that his concerns have not yet been addressed. "Hopefully, I will be able to offer an amendment to correct this inequity in the bill," he said.

Bristol-Myers Squibb is continuing to pursue changes to the language in HR 2887 regarding the right of generic manufacturers to market products that do not include updated pediatric labeling.

One proposal Bristol is understood to be floating is a delay in the effective date for those provisions in the bill, which would essentially exempt Glucophage and BuSpar from the change. ANDAs for generic versions of both products are on hold at FDA while the agency evaluates Bristol's argument that the pediatric labeling changes preclude approval of generics (³ Also see "Bristol Glucophage Managed Care Discounts Will Encourage Switches" - Pink Sheet, 29 October, 2001., p. 24).

Bristol is understood to have told legislative staff that it views the generic labeling language as an unconstitutional "taking," and that it would be forced to file suit if the bill is enacted as written. Bristol's immediate goal may be to delay generic approvals long enough to receive a pending patent on use of Glucophage in low-dose combinations with glyburide (see ⁴ Also see "Bristol Metformin/Glyburide Patent Could Extend Glucophage Exclusivity" - Pink Sheet, 5 November, 2001. ).

The Senate passed pediatric exclusivity reauthorization legislation Oct. 18 (⁵, p. 18). The sponsors of the Senate bill, Sens. Christopher Dodd (D-Conn.) and Michael DeWine (R-Ohio) are working on separate legislation that would appropriate $15 mil. to ensure that anti-bioterrorism drugs are studied to determine proper pediatric dosing.

Pediatric Bill Toll-Free Adverse Event Hotline Is Of Concern To Pharmacy

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