Going 75 Miles an Hour

Feb 15, 2018
Bart Cobert

Pharmacovigilance, Drug Safety and Regulatory Affairs Author & Expert

Going 75 miles an hour… Or when management wants to take risks with drug safety


Recently I had an interesting question posed to me. Someone asked me to help explain to management at his company what happens when the drug safety (DS)/pharmacovigilance (PV) group does not do a good job! Management wanted to know why they needed to continue to invest in more and more resources to report bad things about the company’s products.

Aghast, we discussed this in more detail. We agreed, reluctantly, that the question, from a management, business, resource allocation point of view, was not totally absurd.  Rather, it reflected a viewpoint of pharma company leaders who did not come up through the business but often were “parachuted” in from other businesses or parts of the company that did not deal with clinical or safety issues.

It made me recall a situation some years ago where one of the top corporate leaders of this pharma company rose from the marketing/sales arm of the company and was now in charge of this multi-billion dollar company. He told the staff that he wanted aggressive sales and marketing and research to get drugs to market more quickly! He used the analogy that if the speed limit on the road is 55 miles an hour, he’d like us to go 75 miles an hour but would tolerate 65 miles an hour.  When, gently, he was asked whether FDA or others might criticize us, he responded by saying that he was not troubled by a few “speeding tickets” or “slaps on the wrist” from FDA or unpleasant news articles. In fact, he would be disappointed if we did not get a few kicks from FDA! He took the view that any publicity, even bad publicity, is good and that we would not be punished. We should “push the envelope” to use the buzz words of the day. Needless to say, he did not last long and the company rapidly returned to 55 miles an hour after getting into a small mess with FDA and other agencies.

Nowadays, most management in pharma and in the related vendors, CROs and others dealing with the world of pharmaceuticals are fully aware of the need to obey the laws, regulations and (hopefully) best practices in our business and industry.

Still, management will often request an explanation of what might happen if drug safety did not do a good job. What are the risks to the company? Some enlightened leaders may even ask what is their personal risk if, to put it kindly, more resources were devoted to R&D, sales and marketing and less to DS/PV.

Here then are some of the possible responses:

You Have to Do it By Law

The first and most obvious reason to do safety correctly and well is that it is required under federal law (Food, Drug and Cosmetic Act) and FDA regulations. If your company works in other countries it is also required by almost all nations now, particularly Europe, Canada, Japan, China and other major markets. It must be done.


The Park Doctrine

The Park Doctrine in the US provides that a responsible corporate official can be held personally liable for a misdemeanor (and possible subsequent felony) without proof that he or she acted with intent or even negligence, and even if this corporate official did not have any actual knowledge of, or participation in, the specific offense.

Senior corporate officials can be personally charged if there are violations that involve actual or potential harm to the public particularly if it reflects a pattern of illegal behavior and failure to heed prior warnings.

This is somewhat controversial and shocking as it can hold a person liable even if he or she is not aware of the problem or issue. He or she should have been!

This has been used to prosecute executives at pharma companies for failure to report deaths and other safety issues.

Comment: This is personal executive liability. The management will share the risk.


FDA Inspections

The FDA performs inspections (audits) of the PV and drug safety functions of pharma companies both routinely every few years and at any time “for cause.” The FDA will arrive unannounced and the company must drop everything to respond to the inspection which can last from a couple of days to months (for egregious issues).  Triggers include late expedited or periodic reports, poor quality reports, mergers, new drug acquisitions or launches, a new safety database, social media triggers and whistle-blowers, failure of partners or vendors to forward SAEs, lack of an adequate Quality System, etc.

The results of the inspection may be a report handed to the company at the end of the inspection requiring immediate or rapid corrective actions with periodic progress reports to FDA. The penalties can also include a Warning Letter addressed to the CEO requiring immediate action. All of this is in the public domain, particularly the Warning Letter. Beyond that are consent decrees, fines, withdrawal of the NDA or freezing approval of pending NDAs and even prosecution.

Comment: The company should set up systems to avoid getting into a corrective action situation. Once this starts, it can takes months to years to correct at great cost. One wants impeccable inspections with no or minimal findings.


Harm to the Public Health

Failure to pick up SAEs, product quality problems and safety issues with a company’s products can lead to patient harm and even death. There must be continuous signaling and analysis of safety data to minimize patient risk and harm. There must be a documented process that shows due diligence on the part of the NDA holder or responsible party to search for safety issues. Failure to do this can lead to disasters both for the patients and the company.

FDA realizes that the safety profile of new drugs is often not really known till several years after marketing, that manufacturing processes can sometimes go awry, that occasional late reports and errors can occur. The company must, however, show that it is tracking all of this and responds rapidly and decisively to protect the public health and minimize harm when something occurs.  Written processes (SOPs) must be in place that are actually followed.  A quality group in the company must work to ensure this.

Comment: This is where the company must be a good corporate citizen and act morally and ethically.  If it cannot perform these functions adequately itself it should bring in vendors or personnel who can.


Litigation and Law Suits

Failure in safety matters may lead to law suits from injured patients including class action suits resulting in millions of dollars in costs and potential adverse judgments in court.  This is yet another reason to do good safety work and signaling. The goal is to pick up potential problems and signals early and react appropriately to protect the public and the company.

Comment: This is usually a longer term issue taking months or years to play out.  One always hopes that management will not take a short term view presuming they will not be around to have to deal with the fallout a few years down the road.


Adverse Publicity

With the strength of social media, adverse safety issues can go viral in a matter of hours. It is no longer a newspaper blurb or a TV comment on the six o’clock news but now millions of eyes seeing the problem on Facebook or some other social media site.

Comment: This often will quiet down as the next hot issue hits the social media. But it can still make for very unpleasant times for weeks or months. 


If management still does not understand and provide adequate resources to drug safety and PV, you may want to look for another position elsewhere!



Tags: , ,