The pharmaceutical industry is facing a number of critical challenges. Today, the financial pressure on pharmaceutical companies is growing as patent cliffs and a push toward generics put pressure on the industry. Another difficulty faced by many pharmaceutical companies is the growing call for liability regarding the opioid crisis.
Dr. Michael Basco, a physician and pharmaceutical consultant, explains the issues that pharma companies need to address today in order to succeed.
Generics Competition
The FDA began to push for generic drugs to be marketed faster than in the past, beginning in 2017. The introduction of two generic versions pushes the brand name drug’s price down by 52 percent. While patients and physicians see generics as a positive movement within the pharmaceutical industry, they are not taking into consideration the huge amount of money that is spent on drug development.
Opioid Liability
Pharmaceutical makers involved in the opioid crisis are receiving a great deal of public backlash. They are being blamed for deceptively marketing their drugs to downplay their addictive qualities and for encouraging doctors to prescribe far too many pills at a time. Financial incentives from drug makers played a part in the crisis.
The Department of Justice has become involved in the probe, creating a task force to investigate the crisis.
While the risk of addiction is high for many drugs, these prescriptions still need to be made available to chronic pain patients and others with a demonstrated need for the drug. Government crackdowns will only make it more difficult for pharmaceutical manufacturers to help these people.
Product Liability
While regulators believe that pharmaceutical consulting firms and manufacturers should speed up and streamline the R&D process, this cost-cutting measure could lead to unsafe drugs. Medications are tested less, and this increases the regulatory and safety risks. The regulatory agencies need to understand that R&D is an expensive and lengthy process, and that the extra time is required to make safe and effective drugs.
Counterfeit Drugs
Counterfeit drugs are another serious problem for pharmaceutical companies. Companies must be sure that their overseas manufacturers are following all safety and health regulations. They also need to make sure that their patents are protected by blocking the trafficking of counterfeit drugs. Vendors and third parties will need to put extra safeguards in place to make sure that counterfeit drugs are not entering the market.
Patent Expiration
When drug patents expire, companies scramble to produce competing versions. This takes a great deal of revenue away from the pharmaceutical company that pioneered the drug. Pharmaceutical manufacturers need to come up with ways to extend their drugs’ brand-name time, including different versions, formulations, and delivery methods.
Shift to Data Analytics
The pharmaceutical industry has been said to be in a rut, spending increasing amounts on R&D and yet coming up with fewer advances. Some drug manufacturers have shifted their focus to data analytics, finding out how their existing medications can help a different segment of the population. They are able to analyze huge data sets with the help of AI systems.
Another field that pharmaceutical manufacturers hope to explore is genetics. There are already some genetically targeted drugs available on the market, but with the vast store of genetic knowledge about specific diseases, these could be multiplied in the future.
Focus on Developing Countries
For years, drug companies did not focus their services on the developing world. While rates of certain diseases like AIDS were climbing, pharmaceutical companies claimed that they were unable to lower the costs of their products. This trend has reversed over the past few years, with many different pharma companies creating special versions of their drugs for developing markets. This represents a shift toward greater social responsibility on the part of the pharmaceutical manufacturer.
Challenging Times
With all of these challenges, the pharmaceutical industry must move forward if it hopes to create innovative treatments for the public. Dr. Michael Basco encourages patients and physicians to follow industry trends in pharmaceuticals and to understand how these companies can help the public.
