An incredible story was missed last week by the national media. The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm
In summary, the FDA collects fees from the drug companies to initiate the approval process for drugs. In the radio show’s conclusion: a process for undue influence has been created in the drug approval process.
The continuance of the PDUFA is up for vote again this summer and a foregone conclusion is that the “incestuous relationship” that has been created between the FDA and Pharma will be renewed by Congress.
The missed story is the Amendment to the bill that Congress last week voted down by 96 to 1. ** (http://blogs.nature.com/news/2012/05/vital-fda-bill-plods-though-senate.html Public Citizen reviewed and supported the Amendment presented by Senator Bernie Sanders (Independent – Vt) http://www.citizen.org/documents/2035b.pdf
Public Citizen has tracked the egregious actions of fraud perpetrated by the drug companies against the American people. 214 settlements in 20 years totaling at least $23 billion dollars in fines. There have been very few criminal convictions and it appears that for a drug company who gets caught lying to the American people it simply becomes a cost of doing business.
Bernie Sanders offered an Amendment to the PDUFA bill that was very simple. If a drug company is found guilty of misrepresentation or fraud, they will lose the exclusive rights to the brand name drug moving forward. A concise and clear message to the drug companies that Congress will not tolerate lies coming from the corporate offices of Big Pharma.
On May 24th, Bernie Sanders went down in defeat 96 to 1. A law that made a statement on expecting the drug companies to be honest about their products was defeated 96 to 1.
In conclusion to this blog: I don’t know who lost bigger, Bernie Sanders or the American people.
** Clarification: Rep. Bernie Sanders was the only dissenting vote against the passage of the Senate version of the PDUFA bill. His dissenting vote was a personal statement in opposition to his colleagues voting down his Amendment. The actual Amendment that Rep Sanders introduced was voted against by 88 – 9.