Without the Orphan Drug Act, there would probably be no Biogen Idec, no Genzyme, Alexion Pharmaceuticals.
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One idea is to create an incentive for drugmakers comparable to that in the Orphan Drug Act.
The Orphan Drug Act was passed only because of the support of the National Organization of Rare Diseases.
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But while the Orphan Drug Act increased the amount of research into rare diseases, the field is still vastly underfunded.
Jack Klugman touched the lives of millions of Americans through his support for what ultimately became the Orphan Drug Act of 1983.
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They should start by taking the Orphan Drug Act already over a quarter-century old and using it as a model.
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The Orphan Drug Act, enacted in 1982, provides incentives--including tax credits and exemption from user fees--for the development of drugs for rare diseases.
Before FDA control, which took hold in the years after the Pure Food and Drug Act of 1906, the market was largely without barriers.
Thirty years ago, the Orphan Drug Act provided financial incentives to pharmaceutical companies to develop treatments for rare diseases -- diseases that afflict fewer than 200, 000 people.
As KV Pharma followers may recall, Makena was originally projected to become a big moneymaker after the FDA approved the treatment early last year under the Orphan Drug Act.
The passage of the Orphan Drug Act in 1983 made it financially worthwhile for drug companies to chase treatments for disorders like multiple sclerosis, rare cancers, even rare genetic disease.
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The orphan drug act only gives them eight years of exclusivity, but it does set a precedent for giving companies an extension of their monopoly that is not based on patent protection.
Consider the Orphan Drug Act, passed in 1983.
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Of course, the big show will be the suit against the FDA. The drugmaker has accused the agency of messing with the incentives provided under the Orphan Drug Act and selectively applying policy when it comes to enforcing the law concerning compounding.
The typical clinical trial model may not be best suited for generating evidence that a drug is safe and effective against diseases where patient enrollment can be difficult and diseases progress slowly and unevenly over a long period of time, according to Steven Grossman, who worked on the original Orphan Drug Act in 1983 and is now a policy and regulatory consultant.
What party benefits from the Drug Paraphernalia Act that makes it more of a crime to posses a pipe than the drug used in it?
The Synthetic Drug Control Act (HR 1254) was approved by the House of Representatives on December 8, 2011.
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The firm pleaded guilty to criminal charges of violating the Prescription Drug Marketing Act and was allowed to stay in business.
Andean Nations signed the Andean Trade Preference and Drug Eradication Act (ATPDEA), which replaced the expired Andean Trade Preferences Act (ATPA).
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The High Intensity Drug Trafficking Areas (HIDTA) program, created by Congress with the Anti-Drug Abuse Act of 1988, provides assistance to Federal, state, local, and tribal law enforcement agencies operating in areas determined to be critical drug-trafficking regions of the United States.
WHITEHOUSE: High Intensity Drug Trafficking Areas (HIDTA) Program
Correa's decision to offer the Manta Base to China, refusing to renew the lease to the United States while hypocritically seeking to renew preferential trade privileges under the Andean Trade Promotion and Drug Eradication Act, or ATPDEA, ought to make the US reject the trade agreement with Quito.
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Drug safety legislation could be coupled to the re-approval of the Prescription Drug User Fee Act, a 1997 law that sped up drug approvals by getting drug firms to help pay for the process.
That was when the FDA had a deadline, under the Prescription Drug User Fee Act, to let Pfizer know its decision on the drug.
"I would call it the Drug Lord Protection Act, " Constantine fumed.
Dyax submitted its reply on June 1, 2009, and the FDA set a decision deadline of December 1 under the Prescription Drug User Fee Act (PDUFA).
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In the Food and Drug Administration Modernization Act of 1997, Congress specifically exempted drugs compounded for identified individual patients from the same requirements governing manufactured drugs.
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Instead, the Senate is going to vote soon on a bill that reauthorizes the Prescription Drug User Fee Act (PDUFA), which is set to expire later this year.
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One way to combat this barbarous descent would be to enact the Lethal Drug Abuse Prevention Act, sponsored by Representative Henry Hyde (RepublicanIllinois) and Senator Don Nickles (RepublicanOklahoma).
One way to combat this barbarous descent would be to enact the Lethal Drug Abuse Prevention Act, sponsored by Representative Henry Hyde (R Ill.) and Senator Don Nickles (ROkla.).
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