Regulatory Beat: FDA Under Pressure to Address Drug Safety Issues

Concerns over risky medicines may reduce pressure to expand drug imports while boosting demand for more comparative analysis of therapies.
Feb 01, 2005
Volume 18, Issue 2

The growing alarm over harmful side effects from a number of popular prescription drugs is affecting a range of issues of critical importance for pharmaceutical and biotech manufacturers. Safety concerns may slow down efforts to expand drug importation from foreign nations. The National Institutes of Health (NIH) has halted important clinical trials due to fear that the painkillers under study increase risk for cardiovascular events. Congress is supporting more comparative studies of drugs and medical treatments and may take action to expand requirements for hospitals and physicians to report adverse drug events. The Food and Drug Administration (FDA) is on the defensive, as policymakers propose to revise how the agency evaluates pre- and post-approval drug safety data.

NO SURPRISES The Department of Health and Human Services (HHS) task force on drug importation issued a final report in December that lived up to expectations by opposing any broad opening of US borders to prescription drugs from other countries. The 13-member panel headed by US Surgeon General Richard Carmona ruled out legalizing individual importation for personal use, insisting that such a program would cost up to $3 billion to regulate and would open the door to a flood of unapproved and unsafe products entering the US.

The panel acknowledged, however, that it is feasible for the US to establish a large-scale commercial system to re-import low-cost prescription drugs from Canada, but that such a system would be very expensive to oversee and would not save consumers much money in the end. The report [available at http://www.hhs.gov/importtask-force/report1220.pdf] notes that Congress would have to authorize legal importation and should limit it to certain high-volume, high-cost drugs that would enter the US through a limited number of distribution centers. Such an initiative would require a system for product tracking, pedigree maintenance, and frequent import sampling by FDA, and probably would cost hundreds of millions of dollars to establish and maintain. These costs, combined with price hikes by wholesalers and other intermediaries to cover added regulatory requirements, would further erode any healthcare savings. In the end, manufacturers would lose revenues that ultimately could limit the development of new drugs.

These conclusions were roundly criticized by Congressional Democrats for presenting the same old scare tactics largely to protect US manufacturers from foreign competition. Import opponents claimed that opening up the nation's borders to drugs of unknown origin and questionable quality could aggravate concerns about the safety of the US drug supply. Advocates countered that current policies were not keeping unsafe drugs off the market anyway.

RAISING THE BAR An even more alarming result of recent drug safety disclosures is the research community's growing nervousness about conducting clinical studies that involve pain medications or other high-risk treatments. In December, researchers stopped an important NIH-sponsored cancer study that was testing whether anti-inflammatory drugs might help prevent colon cancer. The data showed some evidence associating Pfizer's Celebrex (celecoxib) with cardiovascular events. However, Pfizer executives decided to keep the COX-2 on the market pending further review of the data — data which the manufacturer believes is fairly inconclusive on the safety front and still may reveal beneficial anti-cancer effects.

A few days later, NIH halted another prominent study due to surprising evidence that patients taking naproxen — but not Celebrex — might experience harmful cardiovascular effects. The three-year-old Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT) had been testing naproxen (Bayer's Aleve) and Celebrex on 2400 elderly patients to see if the medicines might help delay the onset of Alzheimer's disease. Because the study participants were healthy, the sponsors decided it was unethical to expose them to an added risk without clear evidence of an offsetting benefit. Investigators also put on hold additional NIH cancer trials seeking evidence of additional uses for these commonly prescribed painkillers, and some 40 studies testing Celebrex for various purposes are under review.

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