IMDA member Stan Tangalakis says the answer is yes.
is concerned about the issue, to the point of giving assistance to one wholesaler - Port Washington, N.Y.-based RxUSA
- in a class-action lawsuit it initiated against the Food and Drug Administration
, which will enforce the Dec. 1 rule.
is also spreading the word about a lawsuit filed in July by RxUSA
against a number of drug manufacturers and national wholesalers, accusing them of conspiring to shut secondary wholesalers out of the market.
has sent letters to lawmakers, in which he
pointed out that: 1) the big wholesalers have been reluctant to give companies such as Mercury verification or validation of the drugs Mercury purchases from them; 2) at least one of the big companies, McKesson Corp.
, has stopped shipping to secondary distributors in Florida; and 3) drug manufacturers have refused to list Mercury as an authorized dealer of record. (No lawmakers have responded.)
"We've been licensed by the state, and we're ethical operators of our business," says Tangalakis
Even if manufacturers won't consider companies such as Mercury Medical to be authorized distributors, because of insufficient volume, Mercury and others should be considered extensions of the big wholesalers, he
"Why can't we, as a licensed pharmaceutical distributor, be audited three or four times a year, so [the government and public] is assured we are buying through an authorized distributor?
In a letter to drug manufacturers, Tangalakis
made essentially the same case, calling for them to "assist in influencing a more rational, logical approach, which is a logistically sound distribution channel…incorporat[ing] the following -- manufacturer, authorized distributor of record, distributor, to end user."
Concerns about where it might lead
doesn't dispute the need for the tracking of drugs throughout the supply chain, but he
is worried that if current legislation stands, smaller wholesalers will be forced out of business because they cannot produce pedigrees.
is also worried about the onerous requirements to which pedigree legislation might lead.
Procedural packs, for example, might contain multiple drugs.
"If we have to authenticate those drugs, how do we do that?
has one more concern, namely, that the clamor for pedigree will extend to med/surg devices.
Thus far, devices have been spared from pedigree legislation, but the topic has been raised.
believes that the FDA's interest in the so-called unique device identifier, or UDI, does not bode well for device distributors. (See "Got your number," September 2006 IMDA Update.) And Mercury is already facing a $400 licensure fee from state of Louisiana for the privilege of shipping drugs and devices into that state.