Policymakers Need a ‘Hippocratic Oath’ on Prescription Drugs

One of the biggest policy issues Washington has grappled with in recent years is the ever-increasing cost of health care and the ways that it can be brought under control. Since the passage of Obamacare in 2010, Congress has – with mixed results over the past decade – passed a flurry of policy proposals with the goal of making health care more accessible and affordable for American families. 

Since taking office President Trump has added his own mark to the debate by focusing on the role prescription drugs play in affecting health care costs. He has worked to lower prices by negotiating directly with the major pharmaceutical manufacturers and has accelerated the introduction of additional generic drugs into the marketplace to foster competition. 

But while generic drugs have an important role to play in our health care system, we must be careful to hold them to the same standards as their brand-name counterparts. Too often generic drug manufacturers have received the benefit of the doubt from elected officials and regulators in Washington. Several inaccurate assumptions have been made over the years regarding the safety, efficacy and role in the marketplace generic drugs play, often to the detriment of American patients.

Chief among these inaccurate assumptions is that generic drugs are always the same and as safe as their name brand-name counterparts. 

The vast majority of generic drugs are manufactured in overseas facilities, many with substandard manufacturing practices. Issues with data integrity and instances of deliberate fraud abound. Inspectors have caught employees destroying key documents and have uncovered hidden laboratories used to produce fake data misrepresenting drug quality. 

Inspections critical to safeguard the foreign supply of generic drugs meanwhile, are on the decline. Although the number of generic drugs approved by the Food and Drug Administration (FDA) has increased 94 percent since 2014, the number of surveillance inspections done globally – to ensure drug-making plants meet U.S. standards – dropped 11 percent in fiscal 2018. The FDA is suffering from a case of misplaced priorities and the faults in the system are starting to show.

Major recalls have been issued for valsartan and irbesartan, high blood pressure medications known as angiotensin II receptor blockers (ARBs). The medications were found to contain a known carcinogen formerly used in the production of rocket fuel called NDMA and a major investigation has been launched. 

It now appears that the scope of the contamination may very well extend beyond these two drugs. Last month the FDA announced they would be probe of generic drug impurities and would be testing samples of other medicines with similar manufacturing processes.

Another common misconception is that generic drugs always result in lower prices for the consumer. In reality, many generic drugs have undergone significant price spikes in recent years and their manufacturers have been accused of anti-competitive practices.

Numerous news reports have documented the increased costs patents have had to shoulder in recent years for common, well-established generic drugs such as insulin (the price doubled from 2012-2016) and the EpiPen (whose price has increased nearly ten-fold since 2007). 

In other cases, generic drug companies have been accused of colluding to divide market share and increase prices. 44 states recently sued 20 generic manufacturers for price fixing. The Department of Justice is also in the midst of a multiyear investigation into unfair business practices. After successfully convicting two generic drug executives of conspiracy to collude with other drugs makers, reports indicate that additional charges may soon be brought.

As a patient who regularly receives complex and lifesaving drugs for the treatment of a preexisting condition, I have a personal stake in this issue. But all Americans who are concerned about maintaining a supply of safe, effective, and reasonably priced drugs need to be aware as well. Controlling costs and expanding access to health care is important, but lawmakers and regulators need to ensure Americans are protected from unsafe medicines. The Hippocratic oath says to “do no harm” and this should be the first priority of our policymakers when it comes to America’s medical care as well. 

Ken Summers is the former chair of the Health Committee in the Colorado House of Representatives.