Drug & Device News

Recommended Sleep Aid Dosages Lowered

The Food and Drug Administration (FDA) has changed the dosing recommendation for certain sleep aids and is now requiring manufacturers to alter these in their package inserts and other literature. The change affects sleep aid drugs containing the active ingredient zolpidem, including Ambien, Ambien CR, Edluar and Zolpimist and various generics. In a press release, the FDA explained that the new dosage recommendations for women and for some men were prompted by the fact that “[n]ew data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.”

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Compounding Pharmacies: Massachusetts May Institute Tough New Oversights

Massachusetts Governor Deval Patrick started the new year by proposing new rules for compounding pharmacies in that state. If passed, the laws would become some of the most stringent in the country, making Massachusetts a far tougher place for compounding pharmacies to do business than it was when the New England Compounding Center (NECC) started making the national headlines. As of the end of last year, 39 people had died of meningitis allegedly caused by tainted drugs that came from NECC. More than 600 more recipients of NECC's products have also been sickened. The proposed changes to Massachusetts law would, according to a release issued by the Governor's office: 1) Require a special license for sterile compounding so that regulators could better oversee a holder's practices; 2) Authorize the state Board of Pharmacy to assess fines against companies that violate Board policies, a power they do not hold at present; 3) Establish whistleblower protections for pharmacists and other staff members who report wrongdoing by compounding firms; 4) Require out-of-state compounding companies delivering or dispensing products in Massachusetts to obtain a state license; 5) Establish a process for changing the make-up of the Board of Pharmacy so that fewer of its members are practicing in the pharmaceuticals field; the Board would instead be composed of four pharmacists, one nurse, one physician, one pharmacy technician, one quality improvement expert, and three members of the public. “There is no action that we in government can take to prevent all abuses in all industries ' but we must do what we can. This legislation makes patient safety paramount and will help fill the gaps in compounding pharmacy monitoring that allowed NECC to operate in the shadows,” said Governor Patrick. “Together these changes can ensure that the tragic events of last fall never happen again.”

FTC Tougher on Pharmaceutical Mergers

The Federal Trade Commission (FTC) issued a report in January detailing its merger enforcement activity for horizontal mergers (those in which direct competitors seek to combine operations) in the years from 1996 to 2011. Of all types of industry mergers, those that received the most scrutiny were deals involving pharmaceuticals manufacturers. Of the 122 the FTC oversaw in those years, 119 ' nearly 100% ' were asked to alter their deals through some means, such as divestiture. In contrast, out of the 20 proposed hospital mergers during that period, only eight (40%) were subject to some form of FTC enforcement action.

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Recommended Sleep Aid Dosages Lowered

The Food and Drug Administration (FDA) has changed the dosing recommendation for certain sleep aids and is now requiring manufacturers to alter these in their package inserts and other literature. The change affects sleep aid drugs containing the active ingredient zolpidem, including Ambien, Ambien CR, Edluar and Zolpimist and various generics. In a press release, the FDA explained that the new dosage recommendations for women and for some men were prompted by the fact that “[n]ew data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.”

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Compounding Pharmacies: Massachusetts May Institute Tough New Oversights

Massachusetts Governor Deval Patrick started the new year by proposing new rules for compounding pharmacies in that state. If passed, the laws would become some of the most stringent in the country, making Massachusetts a far tougher place for compounding pharmacies to do business than it was when the New England Compounding Center (NECC) started making the national headlines. As of the end of last year, 39 people had died of meningitis allegedly caused by tainted drugs that came from NECC. More than 600 more recipients of NECC's products have also been sickened. The proposed changes to Massachusetts law would, according to a release issued by the Governor's office: 1) Require a special license for sterile compounding so that regulators could better oversee a holder's practices; 2) Authorize the state Board of Pharmacy to assess fines against companies that violate Board policies, a power they do not hold at present; 3) Establish whistleblower protections for pharmacists and other staff members who report wrongdoing by compounding firms; 4) Require out-of-state compounding companies delivering or dispensing products in Massachusetts to obtain a state license; 5) Establish a process for changing the make-up of the Board of Pharmacy so that fewer of its members are practicing in the pharmaceuticals field; the Board would instead be composed of four pharmacists, one nurse, one physician, one pharmacy technician, one quality improvement expert, and three members of the public. “There is no action that we in government can take to prevent all abuses in all industries ' but we must do what we can. This legislation makes patient safety paramount and will help fill the gaps in compounding pharmacy monitoring that allowed NECC to operate in the shadows,” said Governor Patrick. “Together these changes can ensure that the tragic events of last fall never happen again.”