Drug & Device News

High Court Skeptical of Restrictions on Drug Company Access to Prescribing Data

Vermont's law requiring doctors' consent before information about their prescribing practices can be passed on to data mining companies and drug manufacturers may not survive a U.S. Supreme Court decision. In oral arguments before the Court on April 26, several justices indicated concerns that the Vermont Pharmaceutical Data Mining Law could violate the Constitution's First Amendment by discriminating on the basis of the speaker's (drug companies and their sales reps) identity. “You are making it more difficult for them to speak by restricting their access to information that would enable their speech to be most effective,” Justice Antonin Scalia told Vermont Assistant Attorney General Bridget Asay, who was defending the law. Asay responded by noting that drug manufacturers' speech would also “be more effective if they had access to patient information, if they had access to their competitors' trade secrets. There's certainly other information available that they would like to use in marketing, but is not available to them by law. Drug companies have no First Amendment right to demand doctors' prescription information just as they have no right to demand doctors' tax returns.”

Pharmaceutical Companies in More Than Their Share Of Legal Fights

Law360 ' a news publisher that, among other things, tracks federal case activity ' reports that seven of the 10 New Jersey corporations most involved as defendants in current lawsuits are big pharmaceutical companies. These seven, which include Johnson & Johnson and Merck and Co. Inc., account for just over 70% of the active suits in the District of New Jersey (cases that have been dormant since at least the beginning of this year were not counted). Most of these are personal injury suits. For example, Johnson & Johnson is a defendant in 63 active suits, 41 of which are product liability suits seeking personal-injury damages. Merck, meanwhile, is defending 56 suits, 39 of them personal injury cases. The landscape is no better for some of these companies when a nationwide snapshot is taken. For example, Law360 reports that Johnson & Johnson is defending 1,793 lawsuits in federal courts within 45 states, and 1,726 of these are for personal injuries.

FDA Will Provide Forum for Reusable Device Safety Discussion

On June 8 and 9, the U.S. Food and Drug Administration (FDA) will hold a public workshop at which the agency, manufacturers, health care providers and other interested parties will discuss how best to ensure the safety of reusable medical devices. These devices, such as endoscopes, are cleaned and sterilized between uses. Postings to the FDA's adverse event reporting system show that these cleanings are not always successful, however, which can lead to infection when a device is used subsequently. The agency has found that some design features can help, such as making the inner surfaces of devices with long narrow interior channels smooth, and clearly identifying parts that should be replaced with each new use.

Public Citizen Urges Recall of Bed Handles

Consumer advocacy group Public Citizen petitioned the FDA in May to recall bed handles currently being manufactured by Bed Handles Inc. of Blue Springs, MO. Explaining the group's objections to the sale of the company's Bedside Assistant bed handles, Dr. Michael Carome, deputy director of Public Citizen's Health Research Group, said in a release: “Contrary to the manufacturer's claim that the Bedside Assistant bed handles make any bed a safer bed, data previously provided to the FDA demonstrate that these devices can turn a bed into a death trap for patients who are physically weak or have physical or mental impairments.” Public Citizen claims the devices, which are rarely used in hospitals but which are present in many nursing homes, can strangle or otherwise injure frail patients who become entangled in them.

High Court Skeptical of Restrictions on Drug Company Access to Prescribing Data

Vermont's law requiring doctors' consent before information about their prescribing practices can be passed on to data mining companies and drug manufacturers may not survive a U.S. Supreme Court decision. In oral arguments before the Court on April 26, several justices indicated concerns that the Vermont Pharmaceutical Data Mining Law could violate the Constitution's First Amendment by discriminating on the basis of the speaker's (drug companies and their sales reps) identity. “You are making it more difficult for them to speak by restricting their access to information that would enable their speech to be most effective,” Justice Antonin Scalia told Vermont Assistant Attorney General Bridget Asay, who was defending the law. Asay responded by noting that drug manufacturers' speech would also “be more effective if they had access to patient information, if they had access to their competitors' trade secrets. There's certainly other information available that they would like to use in marketing, but is not available to them by law. Drug companies have no First Amendment right to demand doctors' prescription information just as they have no right to demand doctors' tax returns.”

Pharmaceutical Companies in More Than Their Share Of Legal Fights

Law360 ' a news publisher that, among other things, tracks federal case activity ' reports that seven of the 10 New Jersey corporations most involved as defendants in current lawsuits are big pharmaceutical companies. These seven, which include Johnson & Johnson and Merck and Co. Inc., account for just over 70% of the active suits in the District of New Jersey (cases that have been dormant since at least the beginning of this year were not counted). Most of these are personal injury suits. For example, Johnson & Johnson is a defendant in 63 active suits, 41 of which are product liability suits seeking personal-injury damages. Merck, meanwhile, is defending 56 suits, 39 of them personal injury cases. The landscape is no better for some of these companies when a nationwide snapshot is taken. For example, Law360 reports that Johnson & Johnson is defending 1,793 lawsuits in federal courts within 45 states, and 1,726 of these are for personal injuries.

FDA Will Provide Forum for Reusable Device Safety Discussion

On June 8 and 9, the U.S. Food and Drug Administration (FDA) will hold a public workshop at which the agency, manufacturers, health care providers and other interested parties will discuss how best to ensure the safety of reusable medical devices. These devices, such as endoscopes, are cleaned and sterilized between uses. Postings to the FDA's adverse event reporting system show that these cleanings are not always successful, however, which can lead to infection when a device is used subsequently. The agency has found that some design features can help, such as making the inner surfaces of devices with long narrow interior channels smooth, and clearly identifying parts that should be replaced with each new use.

Public Citizen Urges Recall of Bed Handles

Consumer advocacy group Public Citizen petitioned the FDA in May to recall bed handles currently being manufactured by Bed Handles Inc. of Blue Springs, MO. Explaining the group's objections to the sale of the company's Bedside Assistant bed handles, Dr. Michael Carome, deputy director of Public Citizen's Health Research Group, said in a release: “Contrary to the manufacturer's claim that the Bedside Assistant bed handles make any bed a safer bed, data previously provided to the FDA demonstrate that these devices can turn a bed into a death trap for patients who are physically weak or have physical or mental impairments.” Public Citizen claims the devices, which are rarely used in hospitals but which are present in many nursing homes, can strangle or otherwise injure frail patients who become entangled in them.