Laws that protect pharmaceutical companies, as well as consumers, typically fall under federal jurisdiction. Countries regulate the creation, distribution, and sale of pharmaceutical drugs within their borders. In the United States, the Food and Drug Administration (FDA) oversees the approval of newly developed drugs before they reach consumers. However, pharmaceutical companies are also protected by laws that chiefly protect drug companies’ research. Patents protect research and intellectual property. Other regulations on pharmaceutical companies determine when generic equivalents of drugs can enter the market.
While rules and laws regulating drug manufacturers seek to keep consumers’ safety in check, profitability factors in. Sometimes, rules and laws can be taken advantage of in attempt to make a drug more profitable.
Regulations on Pharmaceutical Companies
The FDA’s Current Good Manufacturing Practice (CGMP) regulations ensure the quality of drug products by monitoring drug manufacturers’ compliance. CGMP regulations provide requirements for the methods, facilities, and control measures used in manufacturing. They also dictate processing and packaging compliance for drug products. Overall, the regulations are designed to help make drugs safer by monitoring their ingredients and strength.
The FDA also has the authority to enforce pharmaceutical compliance. Before new drugs go to market, they must undergo extensive clinical testing preceded by basic research and testing on animal models. Throughout these processes, the FDA monitors compliance and study data and ultimately approves or denies a new drug’s sale on the market.
Laws that protect pharmaceutical companies and laws regulating drug manufacturers sit at the intersection of public policy, federal regulations, and intellectual property laws. Consumer protection relies on government oversight. Meanwhile, patents protect pharmaceutical companies’ research and intellectual property.
How Can Laws Regulating Drug Manufacturers Protect Companies from Liability?
While the FDA and other enforcement agencies seek to control drug manufacturing, various laws, policies, and practices protect pharmaceutical companies and drug manufacturers. These policies include:
- Unavoidably unsafe products
- Duty to warn
- Time lapse.
These and similar laws and policies often affect both pharmaceutical companies and drug manufacturers, especially as drug manufacturing duties can overlap.
Unavoidably Unsafe Products
Some prescription drugs cannot be made completely safe, no matter the drug manufacturer’s level of care. “Unavoidably unsafe” products may have harmful side effects but still have beneficial uses. If these drugs are properly manufactured and contain adequate warnings, manufacturers may not be liable.
Duty to Warn
Drug manufacturers have a duty to warn of a drug’s possible side effects, but they are not expected to warn of unknown dangers that might occur in unusually susceptible consumers. Further, manufacturers are responsible for informing doctors and other healthcare professionals of a drug’s side effects. Liability can shift or become blurry when a doctor, as opposed to a manufacturer, should have warned a consumer of possible effects.
If too much time has elapsed between taking a drug and harm becoming apparent, a drug manufacturer may not be held liable. For example, a pregnant woman might take a drug that later harms her grown child. In such cases, evidence may no longer be available or it may be more difficult to identify a drug’s manufacturer. While time lapse does not automatically free a manufacturer from responsibility, it can complicate a case.
Why Can It Be Difficult to Hold Pharmaceutical Companies Accountable?
The False Claims Act (FCA) seeks to hold pharmaceutical companies liable for misleading practices. These might include misbranding and mislabeling products, promoting products for non-FDA-approved uses, failing to disclose potential side effects, misrepresenting study results, and other violations.
Even with the extent of possible violations, it can be difficult to hold drug companies accountable. The FDA regulates both pre- and post-production and marketing. However, given the number of drug companies and voluminous amount of drugs produced, keeping tabs on so much activity proves difficult. Often, whistleblower cases and personal injury claims root out a problem well after it has occurred.
Further, pharmaceutical companies often possess the financial resources to absorb fines and lawsuit settlements involving misconduct. Significant profit and revenue that may or may not be tied to misconduct ultimately outweighs the cost of fines and lawsuit settlements. Essentially, fines and settlements are insignificant compared to profit made.
What Is “Product Hopping”?
Patents protect pharmaceutical companies from generic drug competition. Nevertheless, after 20 years, protective patents expire, and competitors are free to use a manufacturer’s formula to create cheaper generic versions of a drug.
Because availability of generic versions can hurt profits, some pharmaceutical companies seek new patents for a new formulation of the same drug. Minor changes — like switching dosage from twice a day to once a day — may qualify the same drug for a new patent. Changing the drug’s strength or delivery mechanism can also warrant a new patent. By switching consumers to the new formulation before a drug patent expires, pharmaceutical companies can secure another 20-year patent on an otherwise very similar drug.
This practice is known as “product hopping.” While not exclusive to laws regulating drug manufacturers, federal and state antitrust laws seek to prevent practices such as product hopping that limit competition. Still, such cases can get murky, as enabling innovation can be seen as conflicting with competition.
Our Houston Drug Injury Lawyer Is on Your Side
If your health has been damaged by a medication, Terry Bryant Accident & Injury Law wants to hear your story and help you.
A leading Houston drug injury lawyer can help with your claim for damages due to defective drugs or medication errors. Drug injury cases are serious matters, and we have the experience and expertise needed to get drug injury victims the compensation that they deserve.
The relationships we’ve formed with qualified pharmaceutical experts and leading consumer advocates means that we can count on the people and resources needed to support your case.
Contact our team at Terry Bryant Accident & Injury Law today at (713) 973-8888 or toll-free 1 (800) 444-5000 for a free case review.