Drug & Device News

To Combat Drug Shortages, President Orders Changes

President Obama issued an executive order on Oct. 31 directing the FDA to take three steps to lessen the incidence of shortages of important drugs. The agency was instructed to: 1) report potential shortages of important prescription drugs; 2) speed up the review of applications to manufacture these drugs; and 3) report suspicions of collusion or price gouging concerning these drugs to the U.S. Department of Justice (DOJ). Although legislation dealing with the same concerns prompting the executive order has been pending in Congress since early this year, little has been done with the proposed measures. At the same time, a record number of drug shortages have been reported this year, with patients being required to try less effective drugs because the recommended ones simply are not available. Some of the blame for these shortages goes to supply disruptions that occur after safety issues arise at manufacturing plants, shutting down production until satisfactory changes can be made. Other shortages may be caused by ingredient supply-line problems

Researchers Say Weight Affects Vaccine Effectiveness

A study published online in the International Journal of Obesity asserts that flu vaccines are less effective in overweight people as compared with people of normal weight. The study's authors looked at the effects of flu vaccines on 74 people, some of whom were of normal weight, some overweight and some obese. When subjects' antibody levels were tested about a month after they received their shots, the results were about equal in all groups. However, a year later, the antibody levels in the overweight group had dropped at a much greater pace than those of the normal-weight group. Research is continuing to see if the test subjects with lower antibody levels actually contract influenza at higher rates. If so, the authors say, it may be advisable to alter the levels of flu vaccine recommended for overweight patients.

Feds in CA Say They'll Get Tough on Medical
Marijuana Operations

At a news conference held Oct. 7 in Sacramento, the four U.S. Attorneys operating in California announced their intention to begin cracking down on landlords who rent space to medical marijuana dispensaries. While reiterating that they would not prosecute individual patients using marijuana, as promised by the Obama administration in 2009, they emphasized that action must be taken because many so-called medical marijuana dispensaries are in fact illicit drug trafficking operations more intent on money-making than on advancing the cause of public health. Dispensaries and their landlords quickly fired back, going to the courts of the four Federal Districts involved seeking injunctions against federal efforts to step up pressure on the dispensaries.

PA High Court to Decide Which Liability Theories Are Available

When Pennsylvania's State Supreme Court recently reconvened for the current session, one of the more significant issues it was slated to decide was whether plaintiffs can sue drug manufacturers under a handful of state law theories. In Lance v. Wyeth, the defendant will seek to have overturned a three-judge Superior Court panel's ruling allowing plaintiffs to sue a drug maker for negligence resulting in a design defect that causes injury. The plaintiff's side will try for reinstatement of additional theories of liability thrown out by the lower court, including: 1) that drug manufacturers may be held liable for negligently failing to properly test their drugs; and 2) that drug makers may be held accountable for negligently failing to withdraw a product from the market when that product is later recalled by the FDA. Currently, with regard to pharmaceutical products, Pennsylvania recognizes only failure-to-warn claims and those for strict liability based on manufacturing defects.

To Combat Drug Shortages, President Orders Changes

President Obama issued an executive order on Oct. 31 directing the FDA to take three steps to lessen the incidence of shortages of important drugs. The agency was instructed to: 1) report potential shortages of important prescription drugs; 2) speed up the review of applications to manufacture these drugs; and 3) report suspicions of collusion or price gouging concerning these drugs to the U.S. Department of Justice (DOJ). Although legislation dealing with the same concerns prompting the executive order has been pending in Congress since early this year, little has been done with the proposed measures. At the same time, a record number of drug shortages have been reported this year, with patients being required to try less effective drugs because the recommended ones simply are not available. Some of the blame for these shortages goes to supply disruptions that occur after safety issues arise at manufacturing plants, shutting down production until satisfactory changes can be made. Other shortages may be caused by ingredient supply-line problems

Researchers Say Weight Affects Vaccine Effectiveness

A study published online in the International Journal of Obesity asserts that flu vaccines are less effective in overweight people as compared with people of normal weight. The study's authors looked at the effects of flu vaccines on 74 people, some of whom were of normal weight, some overweight and some obese. When subjects' antibody levels were tested about a month after they received their shots, the results were about equal in all groups. However, a year later, the antibody levels in the overweight group had dropped at a much greater pace than those of the normal-weight group. Research is continuing to see if the test subjects with lower antibody levels actually contract influenza at higher rates. If so, the authors say, it may be advisable to alter the levels of flu vaccine recommended for overweight patients.

Feds in CA Say They'll Get Tough on Medical
Marijuana Operations

At a news conference held Oct. 7 in Sacramento, the four U.S. Attorneys operating in California announced their intention to begin cracking down on landlords who rent space to medical marijuana dispensaries. While reiterating that they would not prosecute individual patients using marijuana, as promised by the Obama administration in 2009, they emphasized that action must be taken because many so-called medical marijuana dispensaries are in fact illicit drug trafficking operations more intent on money-making than on advancing the cause of public health. Dispensaries and their landlords quickly fired back, going to the courts of the four Federal Districts involved seeking injunctions against federal efforts to step up pressure on the dispensaries.

PA High Court to Decide Which Liability Theories Are Available

When Pennsylvania's State Supreme Court recently reconvened for the current session, one of the more significant issues it was slated to decide was whether plaintiffs can sue drug manufacturers under a handful of state law theories. In Lance v. Wyeth, the defendant will seek to have overturned a three-judge Superior Court panel's ruling allowing plaintiffs to sue a drug maker for negligence resulting in a design defect that causes injury. The plaintiff's side will try for reinstatement of additional theories of liability thrown out by the lower court, including: 1) that drug manufacturers may be held liable for negligently failing to properly test their drugs; and 2) that drug makers may be held accountable for negligently failing to withdraw a product from the market when that product is later recalled by the FDA. Currently, with regard to pharmaceutical products, Pennsylvania recognizes only failure-to-warn claims and those for strict liability based on manufacturing defects.