According to a spokesperson for House Energy and Commerce Health Subcommittee Chairman Frank Pallone, D-N.J., he and House Oversight and Government Reform Chairman Henry Waxman will introduce legislation before the Independence Day recess that would explicitly state that FDA regulation does not trump medical device patients' ability to seek damages under state law.
"Patients hurt by defective drugs and medical devices would no longer have the ability to seek compensation for their injuries,” Waxman said during a hearing last month on issue. "The result is that one of the most powerful incentives for safety -- the threat of liability -- would vanish."
Okay – once more with feeling, not true. When product manufacturers provide fraudulent information to FDA, or deliberately withhold information about safety problems associated with their products, federal preemption does not protect the manufacturer – and they should be held accountable. The threat of litigation can be an important disincentive to such irresponsible behaviors.
The U.S. Chamber of Commerce's Institute for Legal believes that federal law should trump state statutes when there are inconsistencies between the two. It further argues that preemption allows companies that conduct business in different states one set of rules for compliance, instead of a hodgepodge of laws that stifle growth.
As it should be. Why make being “in compliance” difficult. Doesn’t that ultimately hurt consumers?
An important point to remember is that The FDA’s legal authority over labeling for prescription drugs and biological products is plenary. The Federal Food, Drug, and Cosmetic Act establishes mandatory and prohibited labeling content and manufacturers have no choice but to comply with these requirements. Less obvious, but equally important, is the principle that the Act also constitutes a “ceiling.” In other words, a manufacturer cannot add risk information to labeling unless the FDA has specifically granted its permission.
There is some hope for sanity.
"Current preemption policy is nothing novel or radical, but a dynamic response to an increasingly litigious environment that undermines the effectiveness of the long-established FDA regulatory system," said House Oversight and Government Reform ranking member Tom Davis.
Amen.
Watch this space for more details.
"Patients hurt by defective drugs and medical devices would no longer have the ability to seek compensation for their injuries,” Waxman said during a hearing last month on issue. "The result is that one of the most powerful incentives for safety -- the threat of liability -- would vanish."
Okay – once more with feeling, not true. When product manufacturers provide fraudulent information to FDA, or deliberately withhold information about safety problems associated with their products, federal preemption does not protect the manufacturer – and they should be held accountable. The threat of litigation can be an important disincentive to such irresponsible behaviors.
The U.S. Chamber of Commerce's Institute for Legal believes that federal law should trump state statutes when there are inconsistencies between the two. It further argues that preemption allows companies that conduct business in different states one set of rules for compliance, instead of a hodgepodge of laws that stifle growth.
As it should be. Why make being “in compliance” difficult. Doesn’t that ultimately hurt consumers?
An important point to remember is that The FDA’s legal authority over labeling for prescription drugs and biological products is plenary. The Federal Food, Drug, and Cosmetic Act establishes mandatory and prohibited labeling content and manufacturers have no choice but to comply with these requirements. Less obvious, but equally important, is the principle that the Act also constitutes a “ceiling.” In other words, a manufacturer cannot add risk information to labeling unless the FDA has specifically granted its permission.
There is some hope for sanity.
"Current preemption policy is nothing novel or radical, but a dynamic response to an increasingly litigious environment that undermines the effectiveness of the long-established FDA regulatory system," said House Oversight and Government Reform ranking member Tom Davis.
Amen.
Watch this space for more details.
