FDA Begins to Update Post-Market Procedures, Though Still Lacking
The Government Accountability Office (GAO) has compiled a report looking at the steps the FDA has been taking to improve communication between the internal offices of the FDA, in an effort to protect the public from dangerous drugs released on the U.S. market. The GAO found some FDA efforts towards this goal, including having done or planning to:
· Improve communication between the Office of Surveillance and Epidemiology (OSE, once called Office of Drug Safety) and Office of New Drugs (OND).
· In 2010, implement new data systems facilitating quicker access to outside data, in order to facilitate “timeliness, quality, and analysis of reports of adverse events associated with human drug use.”
· Improve funding for private contracts to provide external data for speedier access.
But is this enough? Within the FDA, scientists in the OND are tasked with reviewing, and ultimately approving, new drug applications. These same scientists are also the ones who (generally) make the determination whether to pull the same drugs off the market. Meanwhile, the OSE monitors the drug’s side-effects on the market and compiles patient complaints. However, the OSE doesn’t have much say in whether the drugs should be pulled from the market. Many outsiders would point to this bureaucratic setup as improper – to have the same scientists which approved the drug also have to be the ones puts the public at risk.
Additionally, the GAO reports that both the OND and OSE are understaffed. Both offices’ employees cite the inability to meet their responsibilities. According to the GAO the OSE must double its employees in the next year in order to keep up with workload. All of this means that both the OND and OSE are understaffed and overworked; and as a result are unable to fulfill their responsibilities.
It’s important to remember that the GAO is fully independent of the FDA, the pharmaceutical industry, and trial lawyers. In fact, it’s an investigative arm of Congress, funded by taxes. There is no incentive for the GAO to fabricate or exaggerate in any direction, and their reports should be taken as truthful and honest. Knowing this makes their reports about the inadequacies of the FDA all the more alarming. While the GAO reports the FDA is going in the right direction, it still has a tremendous amount of ground to make up. And the FDA needs to do much more to distance itself from the pharmaceutical industry. And until this happens, some Americans are at risk of taking FDA-approved medications which should not be on the market.
The FDA Must Improve Communication to Patients
The American Recovery and Reinvestment Act allocated $1.1 billion dollars to coordinate research and guide investments in comparative research funded by the Act. Some critics suggest that a whole lot of money could have been saved just by looking to the FDA.
Dr. Lisa Schwartz and Dr. Steven Woloshin have co-authored a New England Journal of Medicine article titled Lost in Transmission – FDA Drug Information That Never Reaches Clinicians, in which they talk about the fallacies of the current system, and possible ways to correct it. Primarily, on the journey from clinical trials to FDA approval to the production of a drug label, potentially vital information is lost. For example, the FDA approved the drug Rozerem in 2005 to treat chronic insomnia, but in one phase 3 clinical trial, the drug failed to provide any benefit at all for this condition. In fact, a memo created by the FDA’s own medical review team debated whether to even approve the drug since the insignificant benefits provided by the drug may be outweighed by its potential side effects, but Rozerem was eventually approved. Obviously, knowing this background information would certainly appear to have an effect on a doctor’s enthusiasm to prescribe the drug, and a patient’s willingness to take the drug. Unfortunately, though, this type of important information is not placed on the FDA’s approved drug label, so none of it is clearly communicated to the public.
To its credit, the FDA has issued new guidelines about drug labeling, such as including phase 3 trial results and other effectiveness data, but this information is not mandated as it should be. In the case of Rozerem, the effectiveness data is still absent even after the label was updated. Bottom line - more needs to be done.
The FDA is currently undergoing a pilot test of a “drug fact boxes” which would include a succinct table of effectiveness data such as reviews and labels. This would give doctors more pertinent information about drugs and also allow patients to make a more educated decision before they take a new medication. The FDA is still debating internally how to use these “drug fact boxes.”
There are other potential alternatives, but the authors concisely (and correctly) conclude, “Whatever approach the agency adopts, it needs a better way of communicating drug information to clinicians. We don’t need to wait for new comparative-effectiveness results in order to improve practice. We need to better disseminate what is already known.”
FDA’s Oversight of Post-Marketing Studies Inadequate
The Government Accountability Office (GAO) has released a new report about the FDA’s lack of post-marketing oversight in a number of the drugs which it conditionally approved.
The FDA normally makes a decision to approve a drug based on clinical trials. If the clinical trials yielded favorable results, the FDA would then likely approve the drug and sales of the drug can be introduced to the U.S. market. The downside to this traditional route, though, is that the clinical trials can take years to complete, and cost the pharmaceutical company millions of dollars. With this in mind, in 1992 the FDA instituted an optional route to approval: surrogate end-points. Surrogate end-points are the end-results yielded by a drug in a laboratory setting which tend to show positive health benefits. For example, HIV-related drugs are often approved based on its virus-lowering power, a major factor in increased survival for HIV-infected patients. A cholesterol drug could be approved to prevent heart disease, an end-point, by showing that the drug lowers cholesterol – since there is a connection between high cholesterol and heart disease. Utilizing this approval route means that manufacturers can get their drugs to the market faster and patients in need have faster access to the drug.
Unfortunately with surrogate end-point approval there are often many factors unknown, namely long-term effects of the drug’s usage. Long term clinical studies provide this information, but drugs using surrogate end-point trials are often approved so quickly that long-term effects are not known until the drug is on the market - which means that adverse effects may not be known until after the drug’s approval. As such, the FDA approves these drugs conditionally. This means that the FDA will require the manufacturer to conduct ongoing research beyond the drug’s approval, or else the drug’s approval will be revoked.
Despite all of these conditionally approved drugs requiring the conduction of post-marketing studies, the GAO found only 52% of these drugs actually have adequately completed them. 18% haven’t even started, 7% were still ongoing, and 2% were delayed. The remaining 21% were either not yet reviewed or found no longer necessary.
The GAO also noted the FDA’s inability to provide accurate record keeping of post-marketing research. Also, the GAO found that no drug approved under the surrogate-endpoint system has ever been unapproved, despite a large number of delinquent manufacturers.
This is not the first time the FDA has come under fire from the GAO. In 2006, the GAO chastised the FDA for its lack of a clear oversight process, and inability to quickly evaluate post-marketing data. Clearly, the FDA has a responsibility to demand post-marketing studies be completed and submitted to prove a drug’s long-term safety and efficacy.
New Bill Proposes to End Foreign Manufacturer Tort Liability Loopholes
Each year, many people in the United States are injured by defective foreign products imported into the United States. Loopholes in the law give foreign manufacturers ways of delaying lawsuits against them in the United States – but that may be about to change. Currently, when a foreign manufacturer’s product injures someone in the U.S. because of a defect, and the victim files suit against that manufacturer, serving the foreign defendant can take months or even years. As just one example, the recent Chinese-made drywall fiasco is faced with this sort of issue. Foreign manufacturers often seek to avoid judicial consideration of their actions by asserting that United States courts lack personal jurisdiction over their companies. New legislation, however, seeks to make it easier for plaintiffs to establish service and get the lawsuit moving.
In many cases today, serving process on foreign defendants is complicated and time consuming, thanks to international law ratified in the 1960s. Plaintiffs must translate the papers into the manufacturer’s native language, sent to a “central authority” (someone appointed by that country), then serviced per the laws of the country. This can cause huge delays, from a few months to over a year. Newly proposed legislation sponsored in early August by Senators Sheldon Whitehouse, (D-RI), Jeff Sessions, (R-Ala), and Richard Durbin, (D-Ill) called the Foreign Manufacturers Legal Accountability Act of 2009 addresses this problem with a two-pronged solution:
1. Foreign manufacturers will be required to have an “agent” in at least one state, which is designated to accept service on the company’s behalf.
2. Foreign companies consent to state or federal jurisdiction where their registered agent is located upon receiving service.
Obviously, this bill will not affect whether the manufacturer is liability for an injury or make the legal burdens on foreign manufacturers any greater than those imposed on domestic manufacturers. It simply makes service of process work as though the manufacturer were American.
Despite bipartisan support, though, the bill has not passed. But it is important that this important legislation get passed to finally end the loopholes which have allowed foreign manufacturers to delay lawsuits. Foreign companies that import products into the U.S. should not be able to avoid liability simply because of difficulties relating to serving process upon the company.