Pharmceutical Industry

6 Critical Risks Facing the Pharmaceutical Industry

Drug manufacturers face legal, regulatory and technology-related challenges every day.
By: | June 29, 2018 • 3 min read

The pharmaceutical industry is under scrutiny from the government, health insurers and consumers, all calling for greater transparency and accountability. It’s also facing competition from both internal and external forces.

1) Increased Competition from Generic Drugs

In 2017, the FDA began a push to get lower-cost generic drugs out to market faster.

Once a new brand name drug is approved, it’s granted a 180-day period of exclusivity, during which time generic versions cannot go to market. But, a backlog of generic applications has stretched that 180 days much longer. The FDA’s renewed effort to clear that backlog and get generic applications through the approval process faster will flood the market with cheaper versions of high-cost drugs.

According to the FDA, the entree of two competitive generic versions knocks down the price of a brand name drug by 52 percent. The price falls another 30 percent once nine generics are on the market.

2) Legal Liability for Opioid Addiction

Opioid manufacturers are under fire for feeding the epidemic sweeping the nation. Hundreds of lawsuits filed from the local to the federal level accuse drug makers of misleading the public about the addictive properties of opioid painkillers. The suits additionally allege that drug makers exaggerating their benefits and urged doctors to over-prescribe for the sake of increasing revenue.

Now the Department of Justice is getting involved.

Attorney General Jeff Sessions announced the creation of a task force to investigate manufacturers and distributors of prescription opioids. He also said the Department will provide assistance to the prosecution of lawsuits against the drug makers where it can.

3) Product Liability

Beyond promoting competition from generic drugs, the FDA is also urging pharmaceutical companies to cut down the cost of new drugs by streamlining and speeding up the research and development process, which should eliminate some overheard expenses.


While this makes drugs more affordable for consumers, it also means medications spend less time in testing, increasing patient safety risk and regulatory risk.
Policy makers will weigh access to medicines with the desire to encourage biopharmaceutical R&D, which relies on regulatory efforts to streamline clinical research, ensure product quality, and achieve more efficient oversight.

4) Keeping Up with Technology

The study of human genomics is paving the way for personalized medicine, in which drugs are built to work with an individual’s unique set of genes, increasing their effectiveness and safety. 3D printers could emerge as top competitors for manufacturers; the first printed drug was approved by the FDA in 2015. The explosion of personal data collected by wearable devices could enhance the quality of clinical studies and help researchers synthesize results more efficiently.

Nanotechnology could take data collection a step further than wristwatches. Clothing made from nanoparticles could detect more health parameters like internal body temperature, sweat rate, blood pressure, hydration status and more. Medication delivered directly to the cells via nanoparticles in the bloodstream could also revolutionize the way medications are designed.

Failure to keep up with these technology advancements could open the door for non-traditional players to enter the market and infringe on pharmaceutical companies’ market share.

5) Counterfeit Drugs and Global Quality Control

The flow of foreign counterfeit drugs into the American market continues to be a problem, especially as manufacturers move operations overseas.
Multinational pharma companies have to ensure they meet U.S. quality standards while adhering to all local regulations abroad, and are also responsible for blocking for illegal trafficking of counterfeit medications.

This requires stringent standards for all vendors and third parties involved in the manufacture and transportation processes. Brexit will make this more difficult for companies operating out of or distributing drugs in the UK.

6) Patent Cliffs

A patent cliff refers to the expiration of drug patents and the sudden drop-off of sales of products that previously constituted a large percentage of the market. Essentially, patent cliffs put these dollars up for grabs for competitors to produce and patent a comparable brand name drug

In 2022, the industry is expected to have almost $50 billion in prescription drug sales worldwide at risk due to patent expiration, according to market research firm Statista. &

Katie Dwyer is an associate editor at Risk & Insurance®. She can be reached at

More from Risk & Insurance

More from Risk & Insurance

In the Fast-Paced World of Retail, This Risk Manager Strives to Mitigate Risks Proactively and Keep Senior Leaders Informed

Janine Kral works to identify and mitigate risks, building strong partnerships with leaders and ensuring they see her as support rather than a blocker. 
By: | October 29, 2018 • 4 min read

R&I: What was your first job?

My very first paid job was working on my uncle’s ranch in British Columbia in the summers. He had cattle, horses and grapes — an unusual combo. But my first real job out of college was as a multi-line claims adjuster at Liberty Mutual.

R&I: How did you come to work in risk management?

Right out of college I applied for a job that turned out to be a claims adjuster at Liberty Mutual. I accepted because they were offering six weeks of training in Southern California, and at the time that sounded really fun. I spent about three years at Liberty Mutual and then I spent a short period of time at a smaller regional insurance company that hired me to start a workers’ compensation claims administration program.

I was hired at Nordstrom as the Washington Region Risk Manager, which was my first job in risk management. When I started at Nordstrom, the risk management department had about five people, and over the years it has grown to about 75. I’ve been vice president for 11 years.

R&I: What’s been the biggest change in the risk management and insurance industry since you’ve been in it?

I would say that technology has probably been the biggest change. When I started many years ago, it was all paper and no RMIS.


R&I: What risks does the retail industry face that are unique?

We deal with a lot of people — employees and customers. With physical brick and mortar settings, there are the unique exposures with people moving in and out in a public environment. And of course, with ecommerce, we have a lot of customer and employee data, which creates cyber risk — which is not necessarily a unique risk in today’s environment.

R&I: Can you describe your approach to working with senior leaders and front-line staff alike to further risk management initiatives?

It starts with keeping the pulse of what’s happening with the business. Retail moves really fast. In order to identify and mitigate risks proactively, we identify top risk areas and topics, and then we ensure that we have strong partnerships with the leaders responsible for those areas. Trust is critical, ensuring that leaders see us as a support rather than a blocker.

R&I: What role does technology play in your company’s approach to risk management?

Janine Kral, claims adjuster, Nordstrom

We have an internal risk management information system that all of our locations report events into — every type of incident is reported, whether insured or uninsured. Most of these events are managed internally by risk management, and our guidelines require that prevention be analyzed on each one. Having all event data in one system allows us to use the data for trending and also helps us better predict what may happen in the future, and who we need to work with to mitigate risks.

R&I: What advice might you give to students or other aspiring risk managers?

My son is a sophomore in college, and I tell him and his friends all the time not to rule out insurance as a career opportunity. My advice is to cast a wide net and do your homework. Research all the different types of opportunities. Read a lot — articles, industry magazines, LinkedIn. Be proactive and reach out to people you find interesting and ask them about their careers. Don’t be shy and wait for people and opportunities to come to you. Ask questions. Build networks. Be curious and keep an open mind.

R&I: What are your goals for the next five to 10 years of your career?

I have always been passionate about continuous improvement. I want to continue to find ways to add value to my company and to this industry.

R&I: What is your favorite book or movie?

My favorite book is Shantaram by Gregory David Roberts. It’s a true story about a man who was in prison in Australia after being convicted of armed robbery, and he escaped to India. While in India, he passed himself off as a doctor in a slum. It’s a really interesting story, because this is a convicted criminal who ends up helping others. I am not always successful in getting others to read the book because it’s 1,000 pages and definitely a commitment.

R&I: What’s the best restaurant you’ve ever eaten at?

Fiorella’s in Newton, Massachusetts. Great Italian food and a great overall experience.


R&I: What is your favorite drink?

“Sister Carol.” I have no idea what is in it, and I can only get it at a local bar in Seattle. It’s green but it’s delicious.

R&I: What is the riskiest activity you ever engaged in?

Skydiving. Not tandem and without any sort of communication from the ground. Scary standing on a wing of a plane, but very peaceful once the chute opened, slowly floating down by myself.

R&I: If the world has a modern hero, who is it and why?

I can’t think of one individual person. For me, the real heroes are people who have a positive attitude in the face of adversity. People who are resilient no matter what life brings them.

R&I: What about this work do you find the most fulfilling or rewarding?

It’s rewarding to help solve problems and help people. I am proud of the support that my team provides others. &

Katie Dwyer is an associate editor at Risk & Insurance®. She can be reached at