The Trendsetter

Indiana and Pedigree Requirements

2006-02-28T17:44:00.000-05:00

in June 2006 Indiana's pedigree requirements will become a requirement. A wholesale distributor will be able to deny receipt of drugs if the drug is not accompanied by pedigree papers.

IC 25-26-14-14.5
Pedigree required
Sec. 14.5. After June 30, 2006, a wholesale drug distributor may not accept or deliver a legend drug without a current, accompanying pedigree.
As added by P.L.212-2005, SEC.47.

Additionally, effective January 1, 2006, a wholesale distributor seeking to be licensed in Indiana will also have to obtain an accreditation through the Verified-Accredited Wholesale Distributor (VAWD) Program or another board approved acreditation. Accreditation

Please contact Advanced pHarma Trends if you have any further questions regarding this issue.

Advanced pHarma Trends (908) 419-4480

Happy Groundhog's Day

2006-02-02T11:07:00.000-05:00

Nothing to do with business as I am working on a new article which is taking me a little longer than normal. I do, however, want to wish everyone a happy Groundhog's Day. Six weeks of winter like the one we are been having doesn't sound so bad.

Talk to you soon.

Limits on Gifts to physicians

2006-01-25T17:38:00.000-05:00

It has been reported that the pharmaceutical industry spends $21 billion dollars on marketing. This includes gifts given to physicians.

On Wednesday, the Wall Street Journal reported that an article in the Journal of the American Medical Association ("JAMA") calls for stringent limits on the relationships that exist between the doctors and the pharmaceutical industry. Likewise, Medical News Today ran an article similar to the one in the Wall Street Journal. However, the Pharmaceutical Research and Manufacturers of America ("PhRMA") an industry trade group already has adopted voluntary guidelines limiting gifts to physicians, and most states have passed, or are in the process of passing, laws which will restrict gift giving.

At the conclusion of 2005 there was one state that had laws prohibiting any form of gift giving to physicians, one state with a bill pending in committee prohibiting gift giving to physicians and legislation was being introduced in twenty one states restricting the amount a pharmaceutical company is able to spend on gifts to physicians. There is at least one state that currently requires companies to disclose their "gift threshold" on their websites. Most states exclude patient samples from the definition of "gifts to physicians".

For more information contact Ana P. Pierro at Advanced pHarma Trends at (908) 419-4480 or email at appierro@verizon.net

The Prescription Drug Marketing Act and Sample Distribution

2006-01-23T18:49:00.000-05:00

In 1987 Congress passed the Prescription Drug Marketing Act of 1987 ("PDMA") and the president signed it into law on April 22, 1988. In August of 1992 the PDMA was amended. Said amendments established requirements for drug sampling as well as the storage and handling of those samples. Report to Congress

Pharmaceutical companies rely heavily on sampling to get the "word" out about their drug. Giants like Pfizer, Merck and others spend a large portion of their marketing budget on getting samples of their drugs to doctors.

What does this all mean? Well, for starters, pharmaceutical companies have to follow federal regulations (enforced by the FDA) in order to sample their product. However, because states began passing laws and regulations pertaining to sample distribution, companies also have to be cognizant and abide by state laws and regulations. Somes states adopted the federal regulations, but others implemented different regulations (different, not meaning contradictory).

This is the way I look at it: The Federal Law is the ground floor. The state can make their law stricter than the federal but they cannot contradict it or make it less strict. Let me give you an example of what I mean. In the state of washington, if there is a "significant loss" of legend (prescription) drug, the company must notify the board within the next business day of determining the loss. The PDMA (Federal Regulation) requires that the company report the "loss/theft" within five (5) working days and send a report no later than 30 days after notification. 21CFR23.37.

The above is just one example of what a pharmaceutical company has to take into account when distributing samples of a prescription drug in various states. The company must be concerned, not only with the state where the manufacturer/distributor is located but also with the laws and regulations of the various states where the company is distributing their drug.

For more information regarding sampling regulations contact Ana P. Pierro at Advanced pHarma Trends (908) 419-4480 or email appierro@verizon.net