Analysis: Drug Safety is a Fine Line

By STEVE MITCHELL

The pharmaceutical and biotech industries welcomed the Institute of Medicine’s report recommending significant changes in the regulation of drug safety, but both expressed concern about setting the bar too high and impeding new products from reaching the market.

Despite the pharmaceutical industry’s willingness to adopt new ways of ensuring drug safety, it’s concerned about establishing a system that sets unrealistic expectations for safety, Alan Goldhammer, vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, told United Press International.

We all need to remember there are lot of older drugs that work very well but have less than satisfactory safety profiles, Goldhammer said. If we are going to overstigmatize the introduction of new products into the marketplace, we’re doing patients a disservice.

The pharmaceutical industry has already begun implementing many of the changes recommended in the IOM report, he said.

It’s safe to say a number of those recommendation is something companies are already doing and put in as a routine part of business to improve the way drug safety is done at the corporate level, Goldhammer said.

Companies have already made significant changes in drug safety operations over the last five or six years, including looking at innovative ways to acquire data and study drug safety, he added.

Examples of this are risk management plans and setting up databases for making results of clinical trials available. Companies routinely go through to see if there is a need for risk management plans beyond what’s in drug label, Goldhammer said.

The IOM report, which was released last week, recommended a slew of changes in the regulation of drugs, including a significant increase in funding and staffing for the Food and Drug Administration, stronger authority for the agency for post-marketing surveillance and mandatory registration of clinical trials.

The report recommended placing a symbol on labeling denoting that a drug is new and it may have an uncertain safety profile for the first two years its on the market. The report also advised a ban on direct-to-consumer advertising during this two-year period. The FDA should conduct a formal review of the drug five years after its been on the market.

The Biotechnology Industry Organization cautiously welcomed the changes recommended by the IOM report.

We support consideration of efforts to further strengthen the system through increased Congressional funding and the development of new tools to improve drug safety, Jim Greenwood, BIO’s president and chief executive officer, said in a statement.

However, Greenwood also emphasized that a drug approval process that is too stringent could in the end stymie new medications from being approved.

When considering enhancements to the U.S. system, we must be cognizant that implementing undue hurdles in the drug review process will harm patients by delaying access to life-enhancing and life-saving products, he said.

Greenwood told UPI that BIO thinks it’s very important to have a very robust post-marketing program, but that costs money and the agency has to be funded if it’s going to the job well.

To that end, BIO has helped form the Coalition for a Stronger FDA to urge the Department of Health and Human Services to request a substantial increase in FDA’s budget for FY 2008, he said.

The Food and Drug Administration said it has already begun reforming its methods for monitoring drug safety but is open to the strategies outlined in the IOM report.

Much progress and reform of FDA’s safety oversight enterprise is already underway, Andrew von Eschenbach, FDA’s acting commissioner, said in a statement. This includes developing new tools for communicating information to patients and the critical path and personalized medicine initiatives.

I am committed to taking additional steps and will look to the initiatives recommended by the Institute of Medicine, to ensure we continue to fulfill our mission, von Eschenbach added. Over the next months you will be hearing extensively from us about these new endeavors, including a number of initiatives aimed at improving the opportunities for employees of FDA to shape a more effective work environment.

The plans of the FDA and industry may not be enough to satisfy consumer groups.

Bill Vaughan of Consumers Union said the agency and drug manufacturers are not responding nearly as strongly as the IOM recommends.

Vaughan told UPI his group is supporting passage of the Enhancing Drug Safety and Innovation Act, which has been introduced in the Senate. This bill, he said, would give the FDA the authority it needs to force drug companies to respond immediately when there are concerns about a particular drug.

Vaughan said it would be in the best interest of the FDA and drug manufacturers to favor a more stringent post-marketing regulatory process.

A wise pharmaceutical industry would seek a strong FDA that would be able to protect the public against something like Vioxx, he said. The public would have more trust in pharmaceuticals, so this is something they should be working together to clean up their act and not resist.