FDA Considers Dropping Avastin Approval, Approves Five-Day Emergency Contraception Pill

The Food and Drug Administration is considering revoking its approval of a last-ditch breast cancer drug over the debate on "medical spending and effectiveness that flared during the battle over health-care reform," The Washington Post reports. "The [FDA] is reviewing the recommendation of influential scientific advisers to revoke authorization of the drug to treat metastatic breast cancer. Contrary to initial research, new studies indicate that the benefits of the drug, which costs $8,000 a month, do not outweigh its risks, the advisory panel concluded. Citing a dearth of evidence of the drug's effectiveness, its potential toxic side effects, and its high cost, many cancer experts, patient advocates and others are welcoming the prospect that Avastin's authorization for breast cancer might be repealed." But this possibility is causing alarm among some cancer specialists as well as members of Congress and women taking the drug. The drug is prescribed to about 17,500 women a year and is the world's best-selling cancer drug with global sales of $5.8 billion. "The FDA is not supposed to consider costs in its decisions, but if the agency rescinds approval, insurers are likely to stop paying for treatment." Avastin is approved for use in treating colon, lung, kidney and brain cancer, as well as some other forms of the disease. "So doctors could continue to write prescriptions for it for breast cancer, as an 'off-label' use" (Stein, 8/16).

On a separate note, the FDA has approved an emergency contraceptive, ella, that is supposed to block pregnancy for up to five days after sex, "two days longer than the currently available emergency contraceptive Plan B," The Wall Street Journal reports. "The FDA's review of the product reignited a long-running debate over the effects of such emergency contraceptives. Some antiabortion groups argue products such as ella can act to end pregnancies, rather than simply prevent them." Drugmaker Watson Pharmaceuticals says the drug is used to prevent ovulation (Wilde Mathews and Corbett Dooren, 8/14).

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