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Preserving Access to Orphan Drugs Act Encourages Mesothelioma Research

Orphan diseases are those that the pharmaceutical industry has not “adopted” because companies have little financial incentives to create drugs to treat them. These diseases are either very rare, affecting fewer than 200,000 people or are only prevalent in developing countries. There are approximately 5,000 such diseases. Congress is considering a bill called Preserving Access to Orphan Drugs Act of 2011 that would encourage pharmaceutical companies to look for cures or treatments for rare diseases, such as mesothelioma, by removing financial and regulatory impediments that discourage the companies from pursuing such research. Lawmakers drafted the bill, which has bipartisan sponsorship, to clarify previous legislation. The bill has humanitarian intentions and it is important to understand how the bill intends to accomplish its goals and why the nation needs the bill.

The Preserving Access to Orphan Drugs Act would make clear that there is an orphan drug exception to the annual fee that the Affordable Care Act imposes on name brand medications. Congress intended the exceptions to apply to all drugs for orphan diseases, but the way that the I.R.S. interpreted the new law left some drugs for orphan diseases subject to the annual fee. With the Preserving Access to Orphan Drugs Act, Congress would expressly exempt all drugs intended to treat one or more orphan diseases from the annual fee.

The sponsors of the bill recognize the need to encourage drug companies to look for medications that treat orphan diseases. The research that drug companies do could develop medications that benefit a great number of people who suffer from rare diseases. Over 30 million people in the U.S. suffer from orphan diseases. However, the investments needed to find a medication for each of the 5,000 rare diseases is huge when compared to the number of people that the medicine would treat, and Congress did not want to jeopardize further research by levying the annual fee on those medications.

The proposed act could specifically have a positive impact on those who suffer from mesothelioma, a form of cancer that people develop as a result of asbestos exposure. Each year, about 3,000 more people in the U.S. are diagnosed with mesothelioma. This form of cancer takes between 20 to 40 years to develop. Patients often do not show symptoms until they are stage three or four, making it difficult to cure. Current medications for mesothelioma are palliative, but with further research science could find a treatment that is curative. The Preserving Access to Orphan Drugs Act would ensure that drug companies continue to engage in this research.

Mesothelioma can be a devastating disease. If you or a loved one is suffering from mesothelioma, contact an experienced mesothelioma attorney who can discuss your situation with you and advise you of your options.

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