AUTH/2087/1/08: UCB v Flynn Pharma — “Dear Doctor” letter during Equasym shortage and ‘only direct replacement’ claim for Medikinet XL | PMCPA Case

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Key facts

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Case number	AUTH/2087/1/08
Parties	UCB Pharma v Flynn Pharma
Material	Medikinet XL “Dear Doctor” letter
Therapy area	ADHD (methylphenidate immediate/modified release)
Trigger	Supply shortage of UCB’s Equasym (immediate release methylphenidate)
Key claim at issue	“Medikinet XL is the only sustained release methylphenidate available in the UK which is a direct replacement for a b.d. dosage of immediate release methylphenidate”
Complaint received	25 January 2008
Case completed	04 March 2008
Applicable Code year	2006
Breach clauses	Clause 7.2
No breach found	Clause 9.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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Flynn Pharma sent a “Dear Doctor” letter (18 November 2007) to approximately 3,000 paediatricians and 800 child psychiatrists, headed “Shortage of methylphenidate immediate release tablets”.
The letter referred to supply problems with the leading brand of immediate release methylphenidate (identifiable as UCB’s Equasym) and said Flynn was attempting to increase supply of its immediate release methylphenidate tablets (Medikinet).
The letter also promoted Flynn’s modified release product and stated: “Medikinet XL is the only sustained release methylphenidate available in the UK which is a direct replacement for a b.d. dosage of immediate release methylphenidate”.
UCB (which also supplied Equasym XL, a modified release methylphenidate) complained that: (a) issuing such a promotional letter in the context of a competitor shortage failed to maintain high standards (Clause 9.1 allegation), and (b) the “only… direct replacement” claim was not substantiable/misleading given the Equasym XL SPC (Clause 7.2 allegation).
Flynn argued the letter was responsible communication in a sensitive therapy area (ADHD in children), and that its “direct replacement” claim was supported by bioequivalence/clinical equivalence evidence for Medikinet XL; it also argued Equasym XL was not shown to be equivalent in the same way.

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No breach of Clause 9.1: the Panel did not consider that issuing a letter referring to supply problems of a competitor product was necessarily a breach, and did not consider high standards had not been maintained.
Breach of Clause 7.2: the Panel ruled the “only sustained release… direct replacement” claim misleading because the Equasym XL SPC stated patients established on immediate release methylphenidate might be switched to the milligram equivalent daily dose of Equasym XL; therefore Medikinet XL was not the only option.
No appeal.

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