Drug Prices on the Rise

[G-Man]

This is inevitable.  I work for a moderately sized drug company in their Drug Safety/Pharmacovigilance Dept.  This dept is made up of Nurse Practitioners, Dr’s of Pharmacies, and Medical Drs who review ThOUSANDS of adverse events that patients experience while on our drugs during clinical trials and post marketing.  My dept COSTS the company millions without producing a dime.

When an event is reviewed, it is determined whether or not it is serious, expected, and related to the drug.  If it meets criteria, it is reported to the FDA within 15 days of anyone in the company becoming aware of the event.  To help us with this, we have hired a vendor in India that does all of our data entry.  We have developed computer programs to move non-serous cases through the workflows automatically.

Serious cases require mandatory follow-up with the person who reported the event.  NOW, the FDA is requiring follow-up on all cases.  This will require more people, computers, training, etc in order to be in compliance.  This will drastically increase the dept’s budget without return on investment.

Still wonder why drugs cost a lot?

[hubcapsc]

Still wonder why drugs cost a lot?

That great detail on the particular minutia as it relates to drug
prices, but in general I bet there is one answer for everything...

more government regulation = higher prices

-Mike "drugs cost more because people voted for them to cost more"

[G-Man]

You can't imagine the millions spent to maintain Regulatory Compliance.  There is even a dept. in the company called Regulatory Affairs.  Another entire dept. that costs money without producing any revenue.

I hear the following quite often as justification for all this money spent........ We keep the doors open.  If these dept's, as well as several others, fail to do their jobs properly and within compliance, the FDA can shut the company down.  We are audited and inspected by the FDA and EMEA (European FDA) upon their whim.  We have protocols in place on how to behave and what needs to be done as soon as  an FDA representative appears at the reception desk.  When the FDA says jump, the company says "How High?".  I love reading the uninformed posts from people who say the FDA is in the pockets of the drug companies when I see daily how the companies jump through hoops for the FDA.