The US Senate gave their approval to the Food and Drug Administration (FDA), in conjunction with certain pharmaceutical corporations, for a $6.4 billion “agreement fee” in the new Food and Drug Administration Safety and Innovation Act, S. 3187 (FDASI).
Drug manufacturers like Eli Lily & Co, Pfizer Inc, AstraZeneca Plc, and Medtronic Inc will provide regulatory reviews of new medical treatments and healthcare devices. The FDASI extends through to 2017.
The FDASI allocates “use fees” to the FDA as payment for “safety and efficiency reviews”.
The House of Representatives are scheduled to vote on the FDASI next week. And it is anticipated that the bill will be signed into law by Obama in early fall.
The FDASI is part of Obama’s program to use the US government and drug makers together to discover new ways to use old drugs; as well as find new pharmaceutical answers to new diseases.
The focus of this collaboration will identify new uses for drugs that have already been approved by FDA. There may be need for new human trials, putting the general public at a health risk. Engaging in experimental trials to classify specific compounds to be utilized for unintended purposes is highly dangerous.
Drug manufacturers and medical device makers are anxious to work with the US government. This will mean their treatments will be reviewed and approved faster than they currently are. The FDASI specifies that certain measures be taken to expedite the approval of medical treatments under the guise of “life-threatening” or rush monitoring devices to mitigate drug shortages.
The FDASI quite simply ensures more profits for drug corporations.
Senators Tom Harkin and Mike Enzi believe that the FDASI reflects a “kind of cooperation that we see all too rarely in Washington”, referring to the newfound relationship between the pharmaceutical industry and the US government.
The Health Care and Education Reconciliation Act of 2010, signed by President Obama in 2010 allowed generic companies to manufacture complex biologic drugs. These companies paid a fee to the FDA, funding their own right to further manipulate the medical industry without regard for public safety.
Senators Michael Bennet and Richard Burr would have the American public believe that FDASI will give the FDA more authority to “police drugs from manufacturing to distribution to pharmacies”. However, that is exactly the responsibility of the FDA as a regulatory agency designed to ensure public health and safety.
Why would Congress have to give the FDA authority to do its job?
Of course, FDASI benefits the drug corporations by forming a financial relationship with the Pharmaceutical Research and Manufacturers of America and the US government.
Lobbyist groups for corporations like Pfizer Inc have been pressuring Congress to support their over-reaching endeavors.