Over the past several years, a major healthcare policy focus has been on prescription drugs: promoting faster approval methods for new drugs that could save lives (21st Century Cures Act); pushing back against the increasing costs of medications and shifting the market ever more towards generic drugs. Both the Administration and Congress have expressed concerns about the continually rising costs of medications and the lack of price transparency displayed by the drug manufacturers, pharmacy benefits managers, and insurance companies. The movement towards personalized medicine will put an even greater strain on the ability of the government and the insurance companies to approve and pay for more expensive wonder drugs.
While the emphasis on time to market and reducing prescription drugs costs can be very beneficial to individuals’ needs and the cost of healthcare, it is critical that quality and safety not be sacrificed in the process. I recently finished reading Bottle of Lies, by Katherine Eban, an investigative reporter who has reported on the pharmaceutical industry for many years. Her newly published book lays out in shocking detail how the generic drug industry has repeatedly violated quality and safety regulations in their quest to profit from the demand for cheaper generic drugs. Unfortunately, as Eban points out, in a style reminiscent of Upton Sinclair and other muckraking journalists of the early 20th century, generic drugs are mostly manufactured in India and China where safety and quality standards are not enforced in a way that we are accustomed to in the US. This lack of oversight has resulted in many drugs of inferior quality and often questionable safety being shipped to world markets, including the US.
While the USFDA has tried to improve its oversight of the manufacturing plants, Eban describes the Agency as poorly staffed and not sufficiently trained to spot problems in an environment that is far different than the US plants. She describes one major Indian drug manufacturer’s (Ranbaxy) efforts over many years to falsify data, limit product testing, and move manufacturing to locations difficult for auditors to reach. Many of these plants pose significant health risks not only because of manufacturing quality issues but also because they are filthy and insect ridden. Eban also points out that the FDA is buffeted by political forces that are constantly pushing the agency to get more cheap drugs to the markets as quickly as possible. She says in many cases, Agency auditors looking at Indian and Chinese plants have found their adverse findings and recommendations for punitive actions often watered down or dismissed by FDA senior leadership because of political interventions. To be fair to the generic drug industry, there are also safety and quality lapses that occur with manufacturers of brand name drugs as Jeremy A. Greene, the director of the history of medicine at Johns Hopkins University, pointed out in a recent Washington Post review of Eban’s book, which he criticized as one-sided and sensationalized.
Last week, Bloomberg published its own expose of the generic drug industry, describing how a carcinogen got into generic drugs manufactured by a Chinese plant, and the drugs are now being sold in US and other world markets. Bloomberg echoes the Bottle of Lies language, “The FDA has a rigorous approval process for new drugs. Companies conduct clinical trials in humans over several years to prove a drug is safe and effective. But 90% of all medications prescribed to Americans are generics. They are cheaper, they’re supposed to work the same way, and they receive less scrutiny right from the start. Companies’ manufacturing generic drugs have to show only that patients will absorb them at the same rate as the name-brand medications they mimic.” The point is that there are serious concerns about the FDA’s ability to effectively police the ever-growing drug industry and generic drugs are at the heart of that growth. The continuing rise in healthcare costs and increasing use of prescription drugs to cure or control serious medical conditions will ramp up the political pressure on the FDA to move faster and push cheaper alternatives.
Scary stuff. So how can we balance the various healthcare medication needs of cost, effectiveness, quality and availability, all of which are critical? I don’t claim to have all of the answers but a couple of thoughts:
- Congress and the Administration need to make strengthening the FDA’s ability to properly oversee Indian and Chinese drug manufacturing a top priority. This should also include increasing pressure on those two countries’ governments to do a better job of regulating and supporting FDA efforts or the US will begin to develop alternative supply sources for generic drugs.
- There needs to be better consumer education of the potential risks with generic drugs. Generics have played a key role in helping to hold down drug costs, but consumers have been led to believe by the government, drug companies, insurance companies, and their own providers, that generics are always equivalent in quality and safety to name brands but at much cheaper costs. This obviously is not the case in many instances.
- Legislation or executive branch actions around promoting lower drug costs need to always emphasize that quality and safety standards must be maintained as part of that effort, whether generic or not.
We are at a critical point in healthcare in this country. As we move more towards personalized medicine and “designer drugs”, it is critical that we lay out a regulatory and oversight framework that ensures that quality and safety are intrinsically tied to whatever policy and operational approaches become adopted. Otherwise, there is a potential of many tragic impacts to US and other populations that will hurt our ability to continue to rely on cheaper sources of medications to help control healthcare costs.