In a vote almost as close to unanimous as you can possibly get, 403-16, the House of Representatives passed a bill designed to improve drug safety.
The bill, known as H.R. 2900 “FDA Amendments Act of 2007” will now be sent onto the Senate, where there is another bill S. S. 1082, the FDA Revitalization Act. There will be a House and Senate conference on the two bills where they will come up with one bill to send onto the president to sign into law.
The bill goes a long way in expanding the authority of the Food and Drug Administration. The way it is now, the Food and Drug Administration is responsible for making sure a drug is safe in tests and then approving the drug for sale to the public. And that is where their oversight authority ends.
If this bill is put into law, it will give the FDA the authority to oversee the drugs after they are on the market also. With all the drug recalls, and lawsuits in recent years, it seems the industry needs oversight. The drugs will also have to meet new safety requirements.
There will be higher penalties for any drug company found to be in violation of the new standards.
There will also be a system of checks and balances put in place to make sure that any decision the FDA makes is completely unbiased and not influenced by any member of the board of directors of the company involved.
The FDA is authorized to charge a fee, called the Prescription Drug User Fee Act or PDUFA for shot. It is charged to drug companies who want to have their product evaluated faster than they normally would be. The authorization for PDUFA would be extended for another five years. The fee would also be increased and the extra money used for additional staff.
Another current program that has been extended for another 5 years is the Medical Device User Fee and Modernization Act or MDUFMA for short which is basically the same as PDUFA except it allows the FDA to charge fees for reviews of medical devices. This is a big factor. The estimate of revenue from just the fees on medical devices alone is expected to bring in somewhere in the neighborhood of 287 million in fees over the next five years which will amount to only about 20% of what it will cost the FDA to do the reviews of the medical devices.
If a drug company if found guilty of a “false or misleading ad” for prescription drugs faces a fine of $250,000, If there are any more offences within a three year period, the would face a fine of $500,000 per day.
There is a separate section in the bill dealing solely with Pediatric Drug and Devices Development.
The aim of this section is to encourage drug companies to come up with special medical advances for children and to attain that goal, it gives the FDA the authority to require a company to also assess the drugs they are submitting for use in children. This will also apply to situations where the companies are submitting an existing drug to be tested for a new use. This provision will also expire in five years. As an incentive to encourage drug makers to develop drugs that can be used on children, the bill would authorize the FDA to offer them and additional six months exclusive rights to market the drug before another company can market a similar product.
Source: The House Committee on Energy and Commerce :http://energycommerce.house.gov/