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NEWS: Health and Medical
Canada Inuit want action on "catastrophic" TB rate
Sebelius piles pressure on insurers
Kids' tummy bugs tied to irritable bowels
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More cocaine-overdose deaths seen on hotter days
Canadian vaccination study proves 'herd immunity'
Panera to Post Calories at Corporate-Owned Stores
Not ‘War and Peace’ But Orphan-Drug Applications Are Few
The Orphan Drug Act has been around since 1983 offering tax incentives and competition protection for drugs aimed at treating rare diseases. But there have been relatively few orphan drugs developed, so the FDA is beating the bushes for more participation.
FDA staffers recently ran a two-day workshop in Claremont, Calif., to help drug developers fill out the application to get orphan-drug status, the WSJ says in an article this morning. Another workshop is planned for the University of Minnesota in August and there’s talk about doing one in Europe.
There are roughly 350 orphan drugs currently approved, covering about 150 rare diseases. The core requirement for orphan status is that the medicine treats a disease affecting fewer than 200,000 Americans, a limited market that often makes such treatments very expensive. Last year, 250 requests for orphan designation were filed with the FDA, and 160 received it.
Of course, getting more applications doesn’t mean more drugs will make it through the FDA approval process, orphan status or not, the WSJ notes. But the FDA officials with the orphan program hope that increasing the application pool will boost the chances of getting more rare-disease treatments to market.
The first workshop drew 29 potential sponsors, three-quarters of which said they had never filed an orphan-drug application before. Not that the process is really that hard. “It’s not ‘War and Peace,’ ” an FDA official told the WSJ. “The applications are six or seven pages.”
Case history bonus: See here for the story of a mother seeking orphan status for a drug to help her twin girls with a rare but deadly cholesterol metabolism disorder.
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As Health-Care Finale Gets Closer, Both Sides Boost Spending
It’s crunch time in the fight over a health-care bill, so groups for and against the legislation are getting ready for a final push before congressional votes that could come later this month.
These efforts take money, of course, and advocate groups have put together war chests, much of it slated to go to advertising. Here are some of the spending plans outlined in a WSJ report this morning:
- A business coalition backed by the U.S. Chamber of Commerce and other groups will allocate between $4 million and $10 million on anti-bill ads. They will be targeted against several dozen Democratic lawmakers with the message that the changes would cause job losses.
- Another anti-overhaul group, Americans for Prosperity, will use radio and TV ads in about 21 House districts, spending $350,000. It also plans rallies at lawmakers’ district offices.
- Some labor unions and progressive groups called Health Care for America Now are running $70,000 in TV ads in Washington. The ads tell Congress to “listen to us, not the insurance companies. Pass health-care reform now.”
- Seniors group AARP, a heavy spender on TV ads backing a revamp earlier, now is concentrating on contacting constituents in districts with wavering lawmakers to boost support for the bill.
Meanwhile, the health insurance industry is starting to show ads on cable TV networks aimed at blunting White House criticism of insurance rate increases, USA Today reports. The industry group America’s Health Insurance Plans says it’s spending at least $1 million on the ads, but won’t elaborate.
More than $200 million was spent on ads during the overhaul debate last year, making the health-care fight the largest single advocacy campaign ever, according to Campaign Media Analysis Group, which tracks issue advertising. Spending on both sides was about equally split last year, the group tells the WSJ.
Photo of Washington protest Tuesday by Agence France-Presse/Getty Images
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Push to Cure Rare Diseases
Really?: The Claim: A Glass of Wine With Dinner Aids Digestion
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