Wednesday, July 26, 2017

Why Not List Adverse Effects On Drug Labels?

The generic drug market has taken off and grown considerably over the last decade.  Generic drug makers seem to come into the spotlight of the news periodically.  Especially, when a drug has considerable adverse effects.  At that point in time, both the original manufacturer of the medication (drug) and the generic drug manufacturer come under great scrutiny.  Rightly so -- considering the health of the human population.

Recently, I received in my e-mail box a daily list of short excerpts from the news website 'Politico' which detail the stories of the day.   Here is an excerpt from Monday's e-mail regarding generic drugs which might be of importance to those in the population taking medication:

GENERIC DRUG LABELING RULE DEAD FOR NOW: OMB has moved a highly contested FDA rule on generic drug labeling from immediate to long-term priority on its regulatory roadmap for the next year. The rule would require generic drug companies to unilaterally update labels when new safety information emerges. FDA delayed a decision on the final rule last year, saying it would be released in April. Though the rule is dead for now, an FDA spokesperson told Inside Health Policy the agency might consider it "moving forward." Generic drugmakers oppose the rule, which would open them up to new lawsuits. Currently, brand-name drugmakers are supposed to change a label whenever they discover important new information about a drug; only then are generic manufacturers required to follow suit.

Why would any agency allow a manufacturer (drug manufacturer - generic or original) to not list any adverse effects of the drug produced?

The reason why I am astounded by this revelation (or rule) is that the process of drug discovery hinges on updating or optimizing drug data on the population at large.  Readers of this blog will recall the methodology by which drug discovery happens -- which I wrote about in a previous blog post.  In that post, a video detailed (briefly) the process of drug discovery.

Typically, when a drug hits the market or is released to the public, the consumer believes that the drug (or medicine) is totally (100%) safe.  Not so.  As highlighted in the post, there are drug clinical trials which achieve their intended purposes.  Although, further review or monitoring occurs after the medicine is produced for the marketplace.  This includes the updating of learned effects -- whether positive or negative.  At the very least, the adverse effects should be listed on the back of the container -- don't you think?

According to the excerpt above, the adverse effects no longer have to be written by the generic drug manufacture unless the adverse effect is written on the original drug manufactures product.  Furthermore, if the generic drug manufacture does not update the safety information, they will open themselves up to a flood (potential) of legal suits.  Why?

Because, the company had the information on the adverse effects and did not list the adverse effects on their products.  This also assumes that each manufacture's final product (drug or medication) is identical.  Each drug manufacturer makes a "proprietary blend" -- meaning that there chemical composition is different.  Which might raise different adverse effects.  Meaning, a patient taking the original medication might experience complications and not experience the same complications on the generic formulation.  Each of these manufactured products should list the appropriate information.  I am astounded by the FDA's ruling on the matter.

This could result in a number of hospitalizations or death which could have been avoided if the FDA had ruled differently.  As it appears, the FDA does not have your best interest in mind.  At least in folding in to big corporate lobbyists on their drug consultations.  What a terrible condition.  I hope that no one experiences illness or death as the result of the FDA's negligence.  Each of us deserve to have access to the complete set of information regarding medication that is sold on the market place.  The FDA should immediately reverse its ruling and work toward ensuring the health of the US population rather than subjecting it to potential risks.

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