[e-drug] Rx to OTC shifts

["Andy Gray" <andy@healthlink.org.za>]

E-DRUG: Rx to OTC shifts
------------------------
[crossposted from DRUGINFO with thanks.
Copied as fair use. NN]
 
Hi all

Moving drugs from prescription only to pharmacy-only, pharmacist-
initiated or general sales (open shop) status is a well-recognised 
cost saving measure. Apart from price changes, it also shifts the 
burden from insurers to patients. The BMJ this week has this news 
item from the US:

http://bmj.com/cgi/content/full/322/7297/1270/c

The ability of the regulatory authority to enforce non-prescription 
status against the wishes of the manufacturer is also important.

regards
Andy
 
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Andy Gray
Discipline Chair: Pharmacy Practice
School of Pharmacy and Pharmacology
University of Durban-Westville
email: andy@healthlink.org.za
Tel: +27 31 2044358 Fax: +27 31 2044792

~~~~~~

BMJ 2001;322:1270 ( 26 May )

US manufacturers resist moves to sell drugs over the counter

Fred Charatan Florida 

An advisory panel of the US Food and Drug Administration (FDA) 
has voted overwhelmingly that three allergy remedies?loratadine, 
cetirizine, and fexofenadine?are safe enough to be bought at 
pharmacies and supermarkets without a doctor?s prescription. But 
the manufacturers of the drugs are resisting the idea. 

Loratadine and cetirizine are already available over the counter in 
the United Kingdom (as Clarityn and Zirtek respectively), provided 
that the packs do not contain more than 10 days' supply of the 
drug. Fexofenadine, marketed in the United Kingdom as Telfast 
and in the United States as Allegra, is available only on 
prescription in both countries. 

Wellpoint Health Networks, a large Californian insurer, successfully 
argued before the FDA panel that all three drugs are safer than 
many of the other allergy drugs that are already sold over the 
counter. 

Dr John Jenkins, director of the FDA office that evaluates anti-
allergy drugs, said: "We have not identified any serious safety 
concerns with any of these drugs." 

The panel?s vote represents a serious setback for the 
pharmaceutical industry. The three popular anti-allergy drugs 
marketed by Schering-Plough, Pfizer, and Aventis, are heavily 
advertised directly to consumers. The drug companies claim that 
they are better than the older drugs because they do not cause 
drowsiness. 

But they are more expensive. Loratadine, for example, costs $2.13 
(£1.50) a pill in the United States, but in Canada, where it is 
available over the counter, it costs about 50p. Combined sales of 
the three drugs in the United States were $4.7bn last year. 

The drug companies say that Wellpoint is trying to save money by 
shifting the cost from insurers to patients. Wellpoint has said that it 
would save $45m a year if the drugs were available over the counter 
and it were not covering them. 

The drug companies also say that the proposal is against the best 
interests of patients. Dr Robert Spiegel, chief medical officer of 
Schering-Plough, said: "The prescription status of these 
medications is necessary to protect and optimise public health." 

The FDA has not yet switched any drugs from prescription to over 
the counter status on the basis of a third party petitioner without 
the cooperation of the drug manufacturers. Drug industry analysts 
doubt that the FDA has the legal authority to force the companies 
to change the status of the drugs. 

Industry executives said that they would pursue the fight over anti-
allergy drugs inside the Bush administration, which has not yet 
appointed a commissioner of the FDA. The drug companies might 
also take their right to retain prescription status for their products 
to the courts. Such cases could last for years, until the drugs lose 
the patent protection that makes the high prices possible.
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