The proposed rule undermines the 'sameness' requirement in Hatch-Waxman and will result in situations where multiple FDA-approved, therapeutically equivalent products will have different safety-related labeling.
Joe Pitts
The Public Record
Joseph R. Pitts is a former Republican member of the U.S. House of Representatives, serving Pennsylvania's 16th congressional district from 1997 to 2017. During his tenure, Pitts was known for his focus on healthcare, energy, and family issues, often advocating for conservative policies. He played a significant role in various legislative efforts, including those related to the Affordable Care Act and energy independence. Pitts was also involved with the Pennsylvania Family Institute, reflecting his commitment to family values and social issues.
FDA has admitted that the proposed changes will open generic manufacturers up to greater liability under state tort lawsuits.
Would you please provide the Committee with the minutes from this February 2013 meeting?
May I inquire of the time remaining? The SPEAKER pro tempore (Mr. Duncan of Tennessee). The gentleman from Pennsylvania has 10\1/2\ minutes remaining. The gentleman from New Jersey has 12\1/2\ minutes remaining.
At this time, I am pleased to yield 2 minutes to the gentleman from Florida (Mr. Bilirakis), an important member of the Health Subcommittee.
We have groups who have expressed support for this bill: the American Clinical Laboratory Association; the American College of Radiology; Easter Seals; the Family Research Council; the Juvenile Diabetes Research Foundation; the Medical…
I want to read out the title of a blast that I just received from The Heritage Foundation. Some of our Members might be interested in this. ``A temporary SGR patch is better than permanent deficits in support of the bill.'' My colleagues…
I sorely wish I were here getting ready to vote on a bill that would permanently repeal and replace the sustainable growth rate. In this Chamber, we passed a bill that would do that and that would have fully offset the cost of the repeal…
May I inquire of the minority how many speakers they have left? We are prepared to close.
First, I want to thank the gentlelady for hosting this Special Order. This is so important because, tomorrow, the U.S. Supreme Court will hear arguments in the case of Hobby Lobby and Conestoga Wood Specialties against Sebelius. I have the…
I am pleased to yield 1 minute to the gentleman from Nevada (Mr. Heck), another member of the Doctors Caucus.
I reserve a point of order against the motion to recommit. The SPEAKER pro tempore. A point of order is reserved. The Clerk will report the motion to recommit. The Clerk read as follows: Mr. Loebsack moves to recommit the bill H.R. 4015 to…
At this time I am pleased to yield 1 minute to the gentleman from Tennessee (Mr. Roe), another cochair of the Doctors Caucus.
At this time, I yield 2 minutes to the gentleman from Georgia (Mr. Gingrey), one of the cochairs of the Doctors Caucus, who has contributed a great deal to accomplish this bipartisan agreement.
I submit for the Record a letter from the Texas Medical Association in support of this legislation. Texas Medical Association, Austin, TX, March 13, 2014. Hon. Michael C. Burgess, MD, House of Representatives, Washington, DC. Dear…
May I inquire about how much time remains on each side? The SPEAKER pro tempore. The gentleman from Pennsylvania has 10\1/4\ minutes remaining. The gentleman from California has 11 minutes remaining.
At this time, I yield 1 minute to the gentleman from Florida (Mr. Bilirakis), a valuable member of the Health Subcommittee.
At this time, I am pleased to yield 1 minute to the gentlelady from North Carolina (Mrs. Ellmers), who is another important member of the Health Subcommittee.
I withdraw my point of order and claim the time in opposition to the motion. The SPEAKER pro tempore. The reservation is withdrawn. The gentleman from Pennsylvania is recognized for 5 minutes.
At this time then, Mr. Speaker, I yield the balance of my time to the gentleman from Texas, Dr. Burgess, the prime sponsor of this legislation, who has worked tirelessly to achieve this day.
May I inquire of the time remaining. The SPEAKER pro tempore. The gentleman from Pennsylvania has 4\3/4\ minutes remaining. The gentleman from California has 3\1/2\ minutes remaining.
I am very pleased to yield 2 minutes to the gentleman from Michigan (Mr. Upton), the distinguished chairman of the Energy and Commerce Committee, one of the chief architects of this bill.
To begin with, I would just like to acknowledge all the good work on both sides of the aisle in reaching the bipartisan policy agreement in the SGR, and especially want to thank our staff, Clay Alspach and Robert Horne and Chris Pope, and…





