Last week, ahead of the September 23, 2013 compliance deadline for its HITECH final rule (also referred to as the “Omnibus Final Rule”), the Department of Health and Human Services issued guidance entitled “The HIPAA Privacy Rule and Refill Reminders and Other Communications about a Drug or Biologic Currently Being Prescribed for the Individual.” In prior posts, we discussed the HITECH final rulehere, here, and here. The guidance, as you guessed it, addresses the refill reminder exception, from the Omnibus Final Rule, and its two prongs: (1) whether the communication is about a “currently prescribed drug or biologic,” and (2) if the communication involves financial
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, September 26, 2013
Drugmakers would get more FDA scrutiny under draft bill By Steve Walsh, Bloomberg News
The U.S. for the first time would have uniform regulations to help identify stolen or fake drugs, and makers would get more scrutiny, under a draft bill from the Senate and House committees that oversee pharmaceutical safety.
The measure would let the Food and Drug Administration collect and spend fees to cover costs of inspections and licensing. It also would impose handling and record-keeping requirements and create notification rules for drugs that are potentially unsuitable for distribution.
The measure responds to regulatory gaps revealed by investigations into 50 meningitis-related deaths last year that resulted from tainted medications linked to a compounding pharmacy. It would replace a patchwork of state laws governing distribution of drugs through about 4 billion prescriptions a year filled by compounding and traditional pharmacies, the Senate Health, Education, Labor and Pensions and House Energy and Commerce committees said in a statement.
"This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards," Iowa Democrat Tom Harkin, who heads the Senate committee, said in a statement. "This bill also calls for an unprecedented tracing system that will track prescription drugs from manufacturing to distribution."
Counterfeit Imports
The FDA said last year that it had discovered counterfeit versions of Roche Holding AG's cancer medicine Avastin -- with no active ingredient -- in boxes identifying the contents as Altuzan, Turkey's version of Avastin, which hasn't been approved for use in the U.S. In 2008 the FDA recalled Baxter International Inc.'s blood thinner heparin; during the crisis, neither the FDA nor Baxter was able to re-create the supply chain, taking weeks to get close to the source, according to a report last year by the Institute of Medicine, part of the Washington-based National Academies of Sciences.
Under the proposed legislation, manufacturers, repackagers, wholesale distributors and dispensers would, within seven years, be maintaining and sharing records of key information about each drug's distribution history.
The measure would let drug compounders register as outsourcing facilities subject to the same FDA oversight as traditional pharmacies. That would enable the FDA to identify providers and products, get reports on adverse reactions and make risk-based inspections.
FDA Criticized
The FDA came under criticism from Congress for failing to close New England Compounding Pharmacy Inc. before the company shipped fungus-tainted medications to customers across the U.S. in last year's meningitis outbreak. The company subsequently filed for bankruptcy. The FDA told lawmakers that its legal authority over compounding pharmacies needed to be clarified.
The relevant committee chairmen and the panels' top minority members reached a rare bipartisan accord yesterday after the Republican-controlled House passed a supply-chain bill, H.R. 1919, and the Democratic-majority Senate panel approved compounding pharmacy legislation, S. 959.
Compounding pharmacies prepare personalized prescriptions and are regulated by state health authorities. Some companies also produce larger amounts of blended medicines.
A Senate committee staff report released in May found that in the eight months after the meningitis outbreak caused by contaminated compounded drugs, at least 48 compounding companies were found to be producing and selling drugs contaminated or created in unsafe conditions. In at least three cases, visible contamination was spotted in widely distributed sterile compound drugs.
Documented Deaths
continue to read here
The measure would let the Food and Drug Administration collect and spend fees to cover costs of inspections and licensing. It also would impose handling and record-keeping requirements and create notification rules for drugs that are potentially unsuitable for distribution.
The measure responds to regulatory gaps revealed by investigations into 50 meningitis-related deaths last year that resulted from tainted medications linked to a compounding pharmacy. It would replace a patchwork of state laws governing distribution of drugs through about 4 billion prescriptions a year filled by compounding and traditional pharmacies, the Senate Health, Education, Labor and Pensions and House Energy and Commerce committees said in a statement.
"This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards," Iowa Democrat Tom Harkin, who heads the Senate committee, said in a statement. "This bill also calls for an unprecedented tracing system that will track prescription drugs from manufacturing to distribution."
Counterfeit Imports
The FDA said last year that it had discovered counterfeit versions of Roche Holding AG's cancer medicine Avastin -- with no active ingredient -- in boxes identifying the contents as Altuzan, Turkey's version of Avastin, which hasn't been approved for use in the U.S. In 2008 the FDA recalled Baxter International Inc.'s blood thinner heparin; during the crisis, neither the FDA nor Baxter was able to re-create the supply chain, taking weeks to get close to the source, according to a report last year by the Institute of Medicine, part of the Washington-based National Academies of Sciences.
Under the proposed legislation, manufacturers, repackagers, wholesale distributors and dispensers would, within seven years, be maintaining and sharing records of key information about each drug's distribution history.
The measure would let drug compounders register as outsourcing facilities subject to the same FDA oversight as traditional pharmacies. That would enable the FDA to identify providers and products, get reports on adverse reactions and make risk-based inspections.
FDA Criticized
The FDA came under criticism from Congress for failing to close New England Compounding Pharmacy Inc. before the company shipped fungus-tainted medications to customers across the U.S. in last year's meningitis outbreak. The company subsequently filed for bankruptcy. The FDA told lawmakers that its legal authority over compounding pharmacies needed to be clarified.
The relevant committee chairmen and the panels' top minority members reached a rare bipartisan accord yesterday after the Republican-controlled House passed a supply-chain bill, H.R. 1919, and the Democratic-majority Senate panel approved compounding pharmacy legislation, S. 959.
Compounding pharmacies prepare personalized prescriptions and are regulated by state health authorities. Some companies also produce larger amounts of blended medicines.
A Senate committee staff report released in May found that in the eight months after the meningitis outbreak caused by contaminated compounded drugs, at least 48 compounding companies were found to be producing and selling drugs contaminated or created in unsafe conditions. In at least three cases, visible contamination was spotted in widely distributed sterile compound drugs.
Documented Deaths
continue to read here
Drug compounding compromise reached, Lamar Alexander says House, Senate work out bill, but FDA may not support it Sep. 26, 2013 5:18 AM
A compromise bill that supporters say gives the U.S. Food and Drug Administration great regulatory control over drug compounders has been announced by congressional leaders from both the House and Senate, but it is unclear whether it has the support of the FDA itself.
The compromise was disclosed late Wednesday in news releases issued by U.S. Sen. Lamar Alexander, R-Tenn., and a bipartisan group of House leaders, including U.S. Rep. Henry Waxman, a California Democrat.
The agreement comes a year after the beginning of a fungal meningitis outbreak that took the lives of 16 patients treated in Tennessee and 64 nationwide. The deadly outbreak has been blamed on a Massachusetts drug compounding company that shipped fungus-tainted spinal steroids to health care providers in 20 states.
Industry officials said the compromise had been worked out over the weekend, but they expressed concerns the FDA had last-minute objections.
Erica Jefferson, FDA spokeswoman, said she could not immediately comment on the matter. Actual copies of the legislation were not immediately available.
continue to read here
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