Congrats on making through the last 8 weeks. It has been a great experience getting to
know a little about each of you and learning through your perspectives. Good luck in all
your future endeavors.
I personally don’t think there is a single answer to these questions and there certainly is
not right or wrong. I think the best way to answer is to say, “it depends”. Here are two
different examples.
In regards, to Sarbanes-Oxley Act of 2002, I think that the regulations have been good for
businesses – provided there are honest people working on behalf of an organization. Just
today I was working with our internal and an external auditing company as we do on a
yearly basis. They asked for me to provide a sample of data so they could compare that to
what came out of certain GL codes. Through this audit, it was discovered that a member
of the finance team coded a multi-million-dollar line item to the wrong GL code which
affects the brand tied to the GL. Without this regulation, one brand would have had a
surplus (on paper) for the upcoming fiscal year, and the other would have had a large
deficit. This impacts future strategy and bonus structure and payouts for members of those
brands.
On the other hand, government agency such as the FDA have too much oversight, and
control, specifically in the pharmaceutical space … which I happen to work in. Did you
know that 45% of the nearly $6 billion dollar budget comes from what is known “users
fees”, which are fees paid to the FDA by pharmaceutical companies to have their drugs
reviewed and approved? Why do you think companies like Pfizer, J&J, and Moderna were
able to get their Covid-19 vaccines approved in a matter of months when a normal clinical
trial can take anywhere from 3-5 years? It is because large pharma lines the pockets of the
FDA. I will even take it one step further to let you know that one of the heads of the FDA
that approved Pfizer’s Covid-19 vaccine was previously fired from Pfizer when he led the
company and had to pay the largest settlement in pharma history to the tune of $2.3 billion
for felony violation of the Food, Drug, and Cosmetic Act. The point I am trying to make
is that if a pharma company is large enough and has the resources (money) they can sway
the decision-making processes of the FDA for use of pharmaceutical and biomedical
devices. It just so happens that in 27% of the products the FDA approves as safe and
effective, they later have to black box an item because they pushed drugs to market that
did not have long enough clinical studies performed.
After working in this industry for many years, I can honestly say that (1) I am glad that I
do not work in “BIG Pharma”, and (2) just because the FDA or the CDC, or the WHO says
something is safe and effective, it does not mean it is.
References:
Davis, M. (2022, March 17).Government regulations: Do they help
businesses?Investopedia. Retrieved April 19, 2022,
fromhttps://www.investopedia.com/articles/economics/11/government-regulations.asp
Justice Department announces largest health care fraud settlement in its history. The
United States Department of Justice. (2014, September 16). Retrieved April 19,
2022, fromhttps://www.justice.gov/opa/pr/justice-department-announces-largest-
health-care-fraud-settlement-its-history
White, C. M. (2021, May 13).Why is the FDA funded in part by the companies it
regulates?The Conversation. Retrieved April 19, 2022, from
https://theconversation.com/why-is-the-fda-funded-in-part-by-the-companies-it-
regulates-160444
