A study conducted by the Friends of Cancer Research found that most major cancer drugs go through the regulatory process in the US at twice the speed as the equivalent drugs in European nations. The study examined 23 cancer drugs, submitted to regulatory authorities in the US and Europe, over the last seven years. The study concluded that the approval process in the US takes an average of six months, while the same process in Europe takes nearly twice as long.
The study’s results contradict the idea held by many US-based doctors that the most advanced cancer drugs are available in Europe before they reach the US market. Ellen Sigal, the founder and chair of the Friends of Cancer Research group, stated that the nearly six-month gap between US and European markets for crucial cancer drugs is “a potentially life-saving difference.”
The study tracked the approval process for 35 new chemotherapy treatments, 23 of which received approval from both US and European authorities from 2003 to 2010. Nine of the sampled treatments received US FDA approval, but did not win passage from European regulators. Three others were available in Europe, but did not pass the US approval process. The study only examined the review times for those drugs that received approval in both jurisdictions.
Despite the appearances of short review times from US regulators, some drug and medical device manufacturers claim that the process slows down the movement of a potentially beneficial treatment from the lab to the marketplace. Citizen groups that specialize in consumer protection and advocacy claim that such high speeds in the approval stage could allow treatments to reach the market without insuring their safety and efficacy.
FDA officials responded to the study’s publication. Margaret Hamburg, on of the commissioners on the agency’s board, said that the results show the agency’s “commitment to foster access to effective therapies in a responsive and timely manner.” Dr. Janet Woodcock, the agency’s lead drug investigator, said that the FDA was “not in a race” with their European counterparts and that the process they used was “efficient” and “rapid”, but that it also dispelled the “urban myth” about how the best cancer drugs are available in Europe first.
The FDA’s review process blends into other arenas besides medical research. Drug companies and medical device manufacturers rely on FDA approval to get their products to market. The longer the approval process takes, the more time and money the manufacturers must spend waiting with their product on the sidelines. Some investors in the healthcare industry may abandon their stock in companies that have cancer drugs ready for market, but that have yet to receive FDA approval.
The study may also have political fallout. Lawmakers in Congress, confronted with rising budget deficits and climbing debt, have also targeted the FDA for budget cuts. Ms. Sigal and her group have expressed fears that, if the FDA were to feel the bite of the budget axe, the process may be even slower or may not use the proper safety protocols to test the medication needed by so many patients.
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