06.20.12
Congress has passed the U.S. Food and Drug Administration (FDA) user fee reauthorization bill with a voice vote on Wednesday, June 20. The vote passed the FDA Safety and Innovation Act, or S. 1387, by more than two-thirds of the house.
The bill’s main objective is to use the user fees paid by manufacturers to speed up product review and approval times.
The bill, which sets forth several policy reforms pertaining to drugs and medical devices, has at this point been trimmed a little from the earlier House and Senate versions. Key differences include a measure that reflects the Senate version of the bill that would allow the director of the FDA to reclassify a device on administrative order rather than a more burdensome rule-making process. The final, agreed upon wording also requires the FDA to publish a proposed regulation for unique device identifiers by the end of 2012, finalize those regulations by the fall of 2013, and implement a program within two years of the final rule’s publication date.
The lower chamber was happy, overall, with the latest version.
“This bill is good for the FDA, it’s good for industry, and it’s good for patients alike,” said Rep. Frank Pallone (D-N.J.)
Not everyone is completely satisfied, though:
"This bill includes some important reforms that will improve the FDA's ability to monitor medical devices on the market and to notify patients and require stricter testing when safety problems arise," said Lisa McGiffert, who directs a patient safety project with Consumers Union, a consumer advocacy group. "But there is clearly more work that needs to be done to ensure that the FDA has all the tools it needs to ensure medical devices are safe and effective before they can be used on patients."
The advocacy organization is likely miffed about the exclusion of a provision it and other patient advocates fought to be included: a measure to more efficiently track medications from origin to bottling, to prevent counterfeiting. Consumers Union has something to be pleased about though, as the FDA will be required over the next six months to set up a unique device identification system to better track medical devices once they are on the market. The revised bill also includes a provision from the Senate-passed version that requires post-market 522 studies to begin no later than 15 months after being ordered. So-called “522 studies” are conducted for devices that would cause major adverse effects in the event of failure, would affect pediatric patients, will be implanted in the body for over a year, or are life-sustaining. Finally, the bill authorizes the FDA to halt clinical studies it deems too risky for participants.
Next week, the bill will face its final vote in the Senate.
The bill’s main objective is to use the user fees paid by manufacturers to speed up product review and approval times.
The bill, which sets forth several policy reforms pertaining to drugs and medical devices, has at this point been trimmed a little from the earlier House and Senate versions. Key differences include a measure that reflects the Senate version of the bill that would allow the director of the FDA to reclassify a device on administrative order rather than a more burdensome rule-making process. The final, agreed upon wording also requires the FDA to publish a proposed regulation for unique device identifiers by the end of 2012, finalize those regulations by the fall of 2013, and implement a program within two years of the final rule’s publication date.
The lower chamber was happy, overall, with the latest version.
“This bill is good for the FDA, it’s good for industry, and it’s good for patients alike,” said Rep. Frank Pallone (D-N.J.)
Not everyone is completely satisfied, though:
"This bill includes some important reforms that will improve the FDA's ability to monitor medical devices on the market and to notify patients and require stricter testing when safety problems arise," said Lisa McGiffert, who directs a patient safety project with Consumers Union, a consumer advocacy group. "But there is clearly more work that needs to be done to ensure that the FDA has all the tools it needs to ensure medical devices are safe and effective before they can be used on patients."
The advocacy organization is likely miffed about the exclusion of a provision it and other patient advocates fought to be included: a measure to more efficiently track medications from origin to bottling, to prevent counterfeiting. Consumers Union has something to be pleased about though, as the FDA will be required over the next six months to set up a unique device identification system to better track medical devices once they are on the market. The revised bill also includes a provision from the Senate-passed version that requires post-market 522 studies to begin no later than 15 months after being ordered. So-called “522 studies” are conducted for devices that would cause major adverse effects in the event of failure, would affect pediatric patients, will be implanted in the body for over a year, or are life-sustaining. Finally, the bill authorizes the FDA to halt clinical studies it deems too risky for participants.
Next week, the bill will face its final vote in the Senate.