TCS Daily

Reclaiming Medicine for Patients and Physicians

By Gilbert Ross - February 14, 2006 12:00 AM

The FDA has made two remarkable changes in its regulatory approach to drug evaluation and labeling, which will likely lead to more efficiently expedited drug approvals -- as well as to improved flow of important information for doctors to impart to their patients. But these changes have not come without controversy -- as expected with any move by the FDA.

On January 12, Secretary of HHS Leavitt and Acting FDA head von Eschenbach announced that, henceforth, the FDA would allow new chemical entities -- potential new drugs -- to be tested on small groups of patients in small doses as a first step in the process of testing safety in humans. Until now, early-stage trials required large-scale tests with their attendant large-scale costs. Permitting the much lower doses initially will give manufacturers a head start on figuring out which new drugs have a fair chance of surviving the extensive later-stage clinical trials and making a contribution to our health while helping the company's bottom line.

Dr. Sidney Wolfe of Public Citizen, a Naderite group, complained that allowing smaller scale trials would somehow increase the risk of dangerous drugs entering the market. But the new rule would do just the opposite by helping "more researchers conduct earlier, more informed studies of promising treatments so patients have more rapid access to safer and more effective drugs," according to Secretary Leavitt.

This new approach is needed, indeed long overdue. Effective drugs cut medical costs by reducing surgery and hospitalizations for inadequately-treated illnesses. However, only twenty new medications passed the FDA approval process in 2005, almost a record low, as compared to 53 approved in 1996. When beneficial new drugs are rejected, or unduly delayed, patients suffer illness and death. All drugs have risks, however, and risk-benefit discussions should be carried out between doctors and their patients.

On that note, another important change for the better at the FDA was announced on January 18. Overly cryptic prescription drug labels were to be simplified dramatically for doctors. Sounds simple, right? No. The new rule is 275 pages long, and will go into effect June 30th. It mandates reducing the complexity of the information labels which accompany all drugs. Over the past few years, this label has been growing, now running to several fold-out pages containing all manner of data relating to drug side-effects, contraindications and adverse drug reactions (ADRs) -- no matter how irrelevant or rare. These inserts had more closely come to resemble legal disclaimers than useful medical information, which is likely what the drug companies designing them intended.

The new labels will be much more accessible and comprehensible to both doctors and patients. But since the new, simplified labels would be largely devoid of complex legalistic caveats and disclaimers, the FDA also asserted that the new insert, with its highlighted areas of most significant concerns about side-effects and interactions, would pre-empt state courts in their interpretation of required warnings. Thus, the new, streamlined label information would, according to the FDA, be a defense against lawsuits against a drug company alleging failure to warn about some rare side effect or other adverse drug reaction.

As explained by Dr. Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, "These labels need to be reclaimed for patients and physicians." He continued, "We think that if your company complies with FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly-trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge."

This is almost akin to empanelling a "science court" to substitute for the general jury pool in complex litigation against drug companies. Before medication can be prescribed, it must go through years of pre-clinical (animal) testing, followed by years of early-stage human trials, then large-scale trials. After its release into the marketplace, post-marketing surveillance goes on as well. In the middle is the patient's doctor, the "learned intermediary," who is supposed to have independently evaluated the efficacy and safety of a drug as it specifically applies to each patient, and to have discussed possible benefits and risks with each of them before writing the prescription. These facts are now to be taken into account with the new, simplified label and the new hurdle to pass before suing a drug company.

Not surprisingly, these new rules were immediately attacked by trial lawyers and Sen. Ted Kennedy as needless protections for the drug industry. But the critics failed to take note of the fact that if the label on the drug is simplified, the legal protections of including all the various caveats and irrelevant warnings are lost, necessitating the new federal stance preempting state jurisdiction in certain cases. However, just because the FDA asserts their jurisdiction will not automatically make it so -- state courts will come to their own conclusions as to how the FDA rule applies in individual cases.

Dr. Gilbert Ross is medical and executive director of the American Council on Science and Health, a consumer-education and public-health advocacy group advised by 400 scientists and policy experts.


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