Drug & Device News

New Warning Recommends Modest Dosing of Anemia Drugs

The U.S. Food and Drug Administration (FDA) has altered the Boxed Warnings and other enclosed literature in the packaging of Erythropoiesis-Stimulating Agents (ESAs) to indicate that, for safety reasons, they should only be used when absolutely necessary. The agency has determined that when ESAs are used to treat anemia in patients with chronic kidney disease, those individuals are at increased risk of suffering adverse cardiovascular events, including stroke and thrombosis. The drugs Epogen and Procrit (epoetin alfa) and Aranesp (darbepoetin alfa), ESAs approved to treat anemia in patients with chronic kidney disease, were specifically identified in the June 24 FDA release describing the altered package warnings. In announcing the changes, John Jenkins, MD, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said, “Health care practitioners should carefully consider when to begin treatment with an ESA and actively monitor dosing in patients with chronic kidney disease, keeping in mind the increased risk for serious cardiovascular events, and should talk to their patients about these potential risk. The goal is to individualize therapy and use the lowest ESA dose possible to reduce the need for red blood cell transfusions.”

VT Prohibition on Prescribing-Practice Data Mining Shot Down

In its June decision in Sorrell v. IMS Health Inc., 2011 U.S. LEXIS 4794 (6/26/11), the U.S. Supreme Court held Vermont's law against the sharing of physician prescribing data with pharmaceutical companies constituted an unconstitutional restraint on free speech. Vermont's Prescription Confidentiality Law (Vt. Stat. Ann., Tit. 18, ' 4631(d)) prohibited pharmacies from selling information about the prescribing practices of physicians without their permission. (Pharmaceutical companies buy prescriber information from pharmacies so that their salespeople will know what kinds of drugs particular doctors tend to subscribe. With this information they can better target their sales pitches to each individual physician.) Using the mid-level constitutional scrutiny standard, in which a law will be held constitutional if it advances an important governmental interest in a way that is substantially related to the interest, the Court determined that the Vermont statute could not stand. The law, by prohibiting dissemination of prescribing information only to commercial interests while still permitting its publication under several other scenarios, did not substantially protect physician and patient privacy, one of Vermont's stated reasons for imposing the restrictions of its prescription confidentiality law. The second of the State's rationales for the statute was that, by keeping individual prescribing information from drug marketers, public health would be improved and health care costs reduced, because not having access to prescriber information would make it more difficult for pharmaceutical salespeople to sway physicians toward prescribing their expensive products. This, the Court found, was not a permissible reason for placing restraints on speech, as it was “incompatible with the First Amendment.” Drawing analogies to other types of state-disfavored speech, the court noted that states are also not permitted under the First Amendment to “ban campaigning with slogans, picketing with signs, or marching during the daytime. Likewise the State may not seek to remove a popular but disfavored product from the marketplace by prohibiting truthful, nonmisleading advertisements that contain impressive endorsements or catchy jingles. That the State finds expression too persuasive does not permit it to quiet the speech or to burden its messengers.”

Silicone Breast Implants Appear Safe, Though They Are Not Permanent

After reviewing manufacturer-provided safety data compiled after silicone breast implants re-entered the market in 2006, the FDA stands behind its determination that the devices are safe and effective. The two manufacturers that sell silicone breast implants, Allergan and Mentor, were required as a condition of FDA approval of their products that they each conduct six post-approval studies to track the long-term performance and safety of the devices. Those studies have found no causal links between the use of silicone implants and breast cancer, connective tissue disease or rheumatoid arthritis. Despite this, the FDA says it is not yet ready to rule out the possibility of a connection between these diseases and the use of silicone breast implants, as the manufacturers' studies thus far have not involved a large number of subjects, nor have they been carried out for long periods of time.

The June 22 safety announcement also urges women and their health care providers to take into account the fact that breast implants “are not lifetime devices” when making decisions about whether to use them. In fact, 20% of those who receive implants for breast augmentation will need to have them replaced within the first 10 years, while nearly 50% who receive them for breast reconstruction will need to replace them by the 10-year point. Among the reasons for removal are breast hardening around the implant, wrinkling, asymmetry, implant rupture, scarring, pain, and infection.

New Warning Recommends Modest Dosing of Anemia Drugs

The U.S. Food and Drug Administration (FDA) has altered the Boxed Warnings and other enclosed literature in the packaging of Erythropoiesis-Stimulating Agents (ESAs) to indicate that, for safety reasons, they should only be used when absolutely necessary. The agency has determined that when ESAs are used to treat anemia in patients with chronic kidney disease, those individuals are at increased risk of suffering adverse cardiovascular events, including stroke and thrombosis. The drugs Epogen and Procrit (epoetin alfa) and Aranesp (darbepoetin alfa), ESAs approved to treat anemia in patients with chronic kidney disease, were specifically identified in the June 24 FDA release describing the altered package warnings. In announcing the changes, John Jenkins, MD, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said, “Health care practitioners should carefully consider when to begin treatment with an ESA and actively monitor dosing in patients with chronic kidney disease, keeping in mind the increased risk for serious cardiovascular events, and should talk to their patients about these potential risk. The goal is to individualize therapy and use the lowest ESA dose possible to reduce the need for red blood cell transfusions.”

VT Prohibition on Prescribing-Practice Data Mining Shot Down

In its June decision in Sorrell v. IMS Health Inc., 2011 U.S. LEXIS 4794 (6/26/11), the U.S. Supreme Court held Vermont's law against the sharing of physician prescribing data with pharmaceutical companies constituted an unconstitutional restraint on free speech. Vermont's Prescription Confidentiality Law (Vt. Stat. Ann., Tit. 18, ' 4631(d)) prohibited pharmacies from selling information about the prescribing practices of physicians without their permission. (Pharmaceutical companies buy prescriber information from pharmacies so that their salespeople will know what kinds of drugs particular doctors tend to subscribe. With this information they can better target their sales pitches to each individual physician.) Using the mid-level constitutional scrutiny standard, in which a law will be held constitutional if it advances an important governmental interest in a way that is substantially related to the interest, the Court determined that the Vermont statute could not stand. The law, by prohibiting dissemination of prescribing information only to commercial interests while still permitting its publication under several other scenarios, did not substantially protect physician and patient privacy, one of Vermont's stated reasons for imposing the restrictions of its prescription confidentiality law. The second of the State's rationales for the statute was that, by keeping individual prescribing information from drug marketers, public health would be improved and health care costs reduced, because not having access to prescriber information would make it more difficult for pharmaceutical salespeople to sway physicians toward prescribing their expensive products. This, the Court found, was not a permissible reason for placing restraints on speech, as it was “incompatible with the First Amendment.” Drawing analogies to other types of state-disfavored speech, the court noted that states are also not permitted under the First Amendment to “ban campaigning with slogans, picketing with signs, or marching during the daytime. Likewise the State may not seek to remove a popular but disfavored product from the marketplace by prohibiting truthful, nonmisleading advertisements that contain impressive endorsements or catchy jingles. That the State finds expression too persuasive does not permit it to quiet the speech or to burden its messengers.”

Silicone Breast Implants Appear Safe, Though They Are Not Permanent

After reviewing manufacturer-provided safety data compiled after silicone breast implants re-entered the market in 2006, the FDA stands behind its determination that the devices are safe and effective. The two manufacturers that sell silicone breast implants, Allergan and Mentor, were required as a condition of FDA approval of their products that they each conduct six post-approval studies to track the long-term performance and safety of the devices. Those studies have found no causal links between the use of silicone implants and breast cancer, connective tissue disease or rheumatoid arthritis. Despite this, the FDA says it is not yet ready to rule out the possibility of a connection between these diseases and the use of silicone breast implants, as the manufacturers' studies thus far have not involved a large number of subjects, nor have they been carried out for long periods of time.

The June 22 safety announcement also urges women and their health care providers to take into account the fact that breast implants “are not lifetime devices” when making decisions about whether to use them. In fact, 20% of those who receive implants for breast augmentation will need to have them replaced within the first 10 years, while nearly 50% who receive them for breast reconstruction will need to replace them by the 10-year point. Among the reasons for removal are breast hardening around the implant, wrinkling, asymmetry, implant rupture, scarring, pain, and infection.