The U.S. Food and Drug Administration should review drugs on a regular basis for as long as they are on the market in order to catch any new safety issues, according to a report from an independent research body. The Institute of Medicine, which often advises the government on scientific matters, said the FDA should then create a comprehensive, publicly-available document that reflects risks that crop up throughout the “lifecycle” of the drug.
The FDA asked the Institute to evaluate the scientific and ethical aspects of conducting post-market safety studies for approved drugs pursuant to the agency’s authority under the Food and Drug Administration Act of 2007. In the report, the Institute stressed that safety issues involving FDA-approved drugs can arise long after the drugs are evaluated and reach the market, since preapproval studies involve small sample sizes and relatively short time frames.
The FDA has been criticized for not responding quickly enough to dangerous side effects that become more evident after a product is brought to market, such as with Vioxx, a painkiller that Merck & Co. pulled five years after approval because of a link to heart attacks and strokes. “It’s impossible to know all the risks and benefits of a drug before approval,” according Dr. Ruth Faden, co-chair of the Institute’s committee. The Institute called on the FDA to monitor drug safety at regular intervals over time. As we have stated in prior issues, the recommendations by the Institute are not binding. Interestingly, the FDA has expressed some reservations about costs. Sandy Walsh, an FDA spokeswoman, stated:
We support the general concept of enabling the public to be able to clearly monitor relevant safety issues for all drugs. However, we feel it would be very challenging to implement this recommendation within our current resources without seriously compromising other critical regulatory activities.
It is quite obvious that the FDA should have the responsibility to monitor drugs after they hit the market. But apparently that doesn’t always happen. The Institute stated in the report:
The IOM concludes that the FDA’s current approach to drug oversight in the postmarket setting is not sufficiently systematic and does not ensure that it assesses the benefits and risks of drugs consistently over the drug’s life cycle. Adopting a regulatory framework that is standardized across all drugs, yet flexible enough to adapt to regulatory decisions of differing complexity, could help make the agency’s decision-making process more predictable, transparent and proactive. These changes could allow the FDA to better anticipate post-approval research needs and improve drug safety for all Americans.
Currently, the FDA must only check for new safety issues after the drug has been sold for 18 months, or after it has been used by 10,000 patients, whichever is later. It relies upon reports of side effects submitted by the drugmaker, doctors, or patients. The FDA did get greater power under a 2007 law to compel drugmakers to do additional post-approval safety trials or change their labels in response to new information, rather than relying on voluntary action from the companies.
In a report in April, the FDA said it now spends as much effort and resources on tracking a drug after it is approved as it does in the pre-approval process. It said it has required companies to do 385 post-market studies since 2008, and to change the label based on new safety information 65 times. Dr. Faden, who is also director of the Johns Hopkins Berman Institute of Bioethics, said extensive post-approval monitoring is critical because safety concerns with a drug only become apparent once it has been used for many years, and by thousands of patients. Dr. Faden observed:
We’d like to think that when a drug is approved, the evidence is like you need to convict someone at a murder trial: rock solid and without a shadow of a doubt. But that’s not a criterion the FDA could ever use and get drugs out to people in a reasonable amount of time…. exactly how that drug will fare once it’s released is an open question.
We mentioned in this issue the 2011 Supreme Court ruling in PLIVA v. Mensing. This decision held that failure-to-warn claims against generic drug makers, required by law to carry the same warning labels as their brand-name equivalent, are preempted by federal law. We also said that Congress should pass the Patient Safety and Generic Drug Labeling Act, S. 2295. The measure would require generic drug manufacturers to update their warning labels to protect patients from previously unknown side-effects. Again, I hope our readers will ask their U.S. Senators to support S.2295.
Sources: Lawyers USA Online and Insurance Journal
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