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Bio Manufacturers Poised To Follow Senate Victory With House Win
"A veteran California lawmaker with ties to the biotechnology industry said she thinks her proposal to protect brand-name biologic makers has enough support to carry in the House Energy and Commerce Committee," Dow Jones Newswires/Wall Street Journal reports. The proposal, by Rep. Anna Eshoo, D-Calif., would protect brand-name biologic products from competition for 12 years. A similar proposal cleared the Senate health committee earlier this week.
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Vermont Legislature Passes Law Regulating All Drug/Device Company Marketing, Requiring Disclosure Of Gifts To Doctors
The Vermont Legislature has passed legislation (S 48) that bans nearly all gifts from pharmaceutical and medical device companies to health care providers, administrators and facilities in the state, the New York Times reports. The legislation specifically would prohibit drug and device makers from giving providers no-cost meals. Vermont"s legislation would go further than similar laws in other states like Massachusetts and Minnesota by requiring drug and medical device manufacturers who give gifts to health providers to publicly disclose recipients" names and dollar amounts of payments and gifts. The measure would not require manufacturers to disclose payments for clinical research of products undergoing FDA review, the Times reports. The legislation also would eliminate a loophole that allows manufacturers to conceal certain expenses by claiming them as trade secrets. In a recent report, the Vermont Office of the Attorney General said that medical product makers spent about $2.9 million on promotional efforts to the state"s health care providers in fiscal year 2008 and that nearly half of the state"s 4,573 licensed providers had received some type of incentive from drugmakers in the same year. The report, which was developed prior to passage of the new legislation, offers only aggregate data, as 83% of the manufacturer-declared payments were deemed to be trade secrets, the Times reports.Gov. Jim Douglas (R) is expected to sign the law, which would take effect July 1. Several state medical groups -- including the Vermont Association for Mental Health and the Vermont Medical Society -- have indicated support for the legislation.Marjorie Powell, a senior lawyer for the Pharmaceutical Research and Manufacturers of America, said the requirements under the new law appear redundant with new voluntary guidelines the group has issued on physician gifting practices. She said, "We think this is unnecessary, and it is not going to improve patient care," adding, "It makes it onerous not only for the company but also for the physician in Vermont, because this is going to be on a Web site" (Singer, New York Times, 5/20).
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Provectus Pharmaceuticals Initiates New PH-10 Clinical Study For Psoriasis
Provectus Pharmaceuticals, Inc. (OTC BB: PVCT ), a development-stage oncology and dermatology biopharmaceutical company, has initiated a new Phase 2 clinical trial of PH-10 for psoriasis involving daily dosing of patients for 28 days. After reviewing safety and efficacy data from its PH-10 trial for atopic dermatitis, Provectus determined that daily dosing of patients with psoriasis trial would be an appropriate and attractive regimen. The new study supplants an earlier Phase 2 study, using twice weekly dosing for 12 weeks, which was terminated earlier in June.
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British Medical Association Responds To Government's Working Time Directive Training Review

Responding to Health Secretary Alan Johnson"s announcement of a review on the impact of the European Working Time Directive on doctors" training, Dr Andy Thornley, Chair of the BMA"s Junior Doctors Committee, said: "The NHS has had 11 years to prepare for the full implementation of the European Working Time Directive. Whilst we are pleased to see the government finally respond to concerns about the implementation of the directive and the impact it will have on junior doctors" training, this announcement comes just 10 weeks before the 48-hour week becomes UK law. "Junior doctors currently deliver a large proportion of service in hospitals, but they also need time to train to become the consultants and GPs of tomorrow. The reduction in hours that has occurred in preparation for the directive has left many juniors frustrated at the lack of training opportunities as hospitals struggle to maintain the same levels of service in a 48-hour week. "The BMA has repeatedly called on the government to take doctors" concerns about the impact of the directive on training seriously. Whilst a review will be helpful we have proposed a range of practical changes to help protect the standards of junior doctor training. We cannot afford for the high standards of care that patients expect from doctors to be eroded because of poor preparations for the 48-hour limit. "The re-introduction of training lists, for example, would ensure that trainees are able to perform procedures which are suitable for their stage of training. We have proposed increasing the flexibility of training programmes so that doctors can take more time to progress and gain appropriate experience. It is also crucial that the NHS invests in simulators and skills labs, where doctors can practise techniques using technology which simulates a procedure or operation, and that consultant trainers have protected time to supervise junior doctors. "We also need to look at how healthcare is delivered in the NHS. The heavy reliance on junior doctors to provide service to patients will need to move towards a system that is more reliant on consultant based care. To achieve this, the NHS will need to look at focused consultant expansion. "We hope the review will move swiftly so that there is time to implement the range of practical changes that the BMA has been proposing before the August 1st deadline." British Medical Association


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