The direct-to-consumer (DTC) advertising of prescription drugs and the high cost of these drugs are two intertwined and contentious issues in American health care today.
California Western’s Professor Robert Bohrer tackles these issues head-on in two scholarly papers recently published in notable law journals. Both articles lay bare the issues and propose new ideas to address these ever-expanding concerns.
In a paper published in the University of Maryland’s Journal of Health Care Law & Policy, Bohrer contends that DTC advertisements are misleading and that concise statements of effectiveness should be required.
Unfortunately, the marketing strategy of most pharmaceutical companies includes hiring energetic and attractive actors to fill the TV screens of American households with images of happy and healthy patients in comforting surroundings. These costly ads tout broad-based benefits offset by some “potential” side effects.
“The reason for this,” contends Bohrer, “is that these companies do not have the data that would make choosing their drug a rational, rather than subjective or arbitrary choice—so they have to appeal to their viewers’ emotions and their desire to feel better, live longer, or get more sleep.”
Bohrer’s proposed solution is for the Food and Drug Administration (FDA) to use its power to regulate drug labeling requiring DTC ads to contain a concise and clear statement of the expected benefit provided by the drug. This required disclosure would be based on data from trials that supported the FDA approval of the advertised statements or on post-marketing studies that had been reviewed and approved by the FDA.
In a separate paper published in the Drexel Law Review, Bohrer deals with two issues that have been major topics in the news for much of the past year. First, the high cost of new drugs, particularly the “specialty” drugs developed for serious diseases; and second, the time required for FDA approval in relation to the need for earlier access to new therapies for critically ill patients.
“Lurking behind both issues,” says Bohrer, “is the need for better information for physicians and patients to use in making decisions about prescribing and taking these drugs. Insurance companies and the government also need to construct a structured benefit plan that would control cost and allow early access to specialty drugs. In the current system, drugs for critically ill patients are entering the marketplace without any evidence that they will actually provide a real benefit to patients.”
Bohrer proposes accelerating access to specialty drugs and restricting the price pharmaceutical companies can charge with a new form of conditional approval by the FDA similar to the parallel track program developed by the FDA in the 1990s, during the HIV crisis.
This conditional approval would allow distribution of specialty drugs to the most desperate patients before final FDA approval was permitted by the parallel track initiative. Conditional approval would restrict the price of the conditionally approved drugs until sufficient data could be collected to warrant full approval. Patients would still get the drugs before all the evidence is in, but the price of the drugs would be reduced until we actually know whether or not the drugs really work.
“With the high cost of prescription drugs straining the health care system and pharmaceutical companies under pressure to lower prices, these new ideas would be good for patients and good for us all,” concludes Bohrer.
To read Professor Bohrer’s article in the University of Maryland’s Journal of Health Care Law & Policy, click here.
To read Professor Bohrer’s article in Drexel Law Review, click here.