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FDA Requests Higher User Fees from Industry
The acting head of the U.S. Food and Drug Administration (FDA) defended the agency's request for more funding, including an increase in fees from industries the agency regulates.
Democrats debating the FDA's budget voiced concern that annual increases in industry fees might compromise the agency's work.
Acting FDA Commissioner Joshua Sharfstein says he understands the concern that people have expressed that user fees create a perception or a conflict of the agency's work, but he also thinks these concerns reflect a broader lack of trust in the FDA.
For fiscal 2010, the president has asked for an FDA budget of $3.2 billion, including $828 million in fees from manufacturers of medical and food products. The fees include hundreds of millions of dollars that drug makers pay annually to help speed the review of new medicines. The plan also seeks new fees to help clear a backlog of generic drug applications and to reinspect food and medical product plants that fail to meet FDA standards.
The Acting Commissioner also said he did not think the industry fees had risen too high.
http://www.reuters.com/article/rbssHealthcareNews/idUSN2142784220090521
Drug-company Executives Working to Prevent Steep Cuts in Prescription Prices
Pharmaceutical industry executives are using a different approach to try to steer lawmakers away from measures that could reduce drug margins, pressing instead for cost reductions by hospitals and insurers.
In their meetings at the White House and on Capitol Hill, industry executives and lobbyists have backed such steps as shifting insurance coverage toward prevention, which could increase sales of drugs for the treatment of heart problems, diabetes, and other drugs that patients take long term.
Executives state that a healthcare overhaul should tackle the insurance copayments that he says deter patients from taking the drugs they need. Reforms shouldn't force doctors and patients to choose a drug based on cost if the more expensive treatment would have a better outcome.
Pfizer Chief Executive Jeffrey Kindler says he opposes a public insurance plan except for the poor who otherwise can't afford insurance, saying it would crowd out private insurers and take "the form of price controls" that fail to reward companies for their expensive and risky investments in drug development.
Extending health insurance coverage to millions of uninsured Americans is likely to benefit drug makers with estimates that such a move could increase the $291 billion in annual U.S. prescription-drug sales by $15 billion to $18 billion.
To help accomplish their goals, the drug makers spent $47.4 million on lobbying in the first quarter, up 36% from a year earlier. Pfizer has more than doubled its spending on lobbying in the period to $6.1 million.
Drug makers joined doctors, insurers, and hospitals earlier this month in a pledge to rein in healthcare cost increases by $2 trillion over the next decade. Merck & Co. Chief Executive Richard Clark stated the company was "ready to do our part to achieve" an overhaul.
The pharmaceutical industry has been significantly increasing their prices. Prices for many drugs were up more than 15% in the first quarter from a year earlier. Pharmaceutical companies say the increases are fair and necessary as drugs mature, but analysts say the companies are trying to obtain as much revenue as they can before patents expire and healthcare reform drives down prices.
Peter Rost, a former marketing executive at Pfizer who is now an industry critic, says the increases are a way to soften the impact of future price cuts. "Ahead of these give-backs, they dramatically raise prices," Dr. Rost says. "They always do that."
Meanwhile, drug-industry executives worry that lawmakers might give Medicare—the existing public program for the elderly and disabled—the authority to negotiate the prices for drugs dispensed through its Part D benefit. This would limit the prices pharmaceutical companies can charge.
http://online.wsj.com/article/SB124338375682356635.html?mod=dist_smartbrief
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