House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period

    By Donald Zuhn --

On Friday, the House Committee on Energy and Commerce approved a health care reform bill by a narrow three-vote margin (31-28).  The bill (H.R. 3200), entitled "America's Affordable Health Choices Act," was originally introduced in the House on July 14, 2009 by Rep. John Dingell (D-MI).

According to a statement released by the Committee, the bill will "build on what works in today's health care system, makes important insurance market reforms to protect consumers, encourages competition among insurance plans to improve choices for patients, and expands access to quality, affordable health care for all Americans."  Committee Chairman Henry Waxman (D-CA) called the passage of the bill "a historic moment for the House of Representatives and a defining moment for our country," adding that the bill "will deliver the results the nation's health care system so desperately needs:  lower costs, better quality, and broader coverage."  Chairman Waxman said that he hoped that the House would pass the bill when it returns from recess.  The Energy and Commerce Committee's bill will be merged with provisions reported by the Committees on Ways and Means and Education and Labor for consideration by the full House of Representatives.

The Committee also announced a series of mark-ups to the bill that were introduced prior to the Committee's vote.  One of the mark-ups was an amendment offered by Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX) that is similar to the follow-on biologics legislation (H.R. 1548) Rep. Eshoo (at left) introduced in March.  In particular, the amendment outlines a licensure pathway for biosimilar biological products that includes a provision preventing the FDA from approving a biosimilar application until 12 years after the date on which the reference product (i.e., the innovator biologic) was first licensed.  The amendment was passed by the Committee by a comfortable 41-11 margin.  Voting against the amendment were Chairman Waxman and Representatives Dingell, Frank Pallone, Jr. (D-NJ), Lois Capps (D-CA), Janice Schakowsky (D-IL), Anthony Weiner (D-NY), Kathy Castor (D-FL), John Sarbanes (D-MD), Betty Sutton (D-OH), Peter Welch (D-VT), and Nathan Deal (R-GA).  The votes by Representatives Pallone, Capps, Schakowsky, and Sarbanes were not altogether surprising, given that the four Committee members are co-sponsors of Chairman Waxman's H.R. 1427, which provides up to 5.5 years of exclusivity (as of Friday, Chairman Waxman's bill had the support of 14 co-sponsors while Rep. Eshoo's bill enjoyed the support of 142 co-sponsors).

The Committee's passage of H.R. 3200 marked the second victory this month for organizations, trade groups, and companies seeking a longer (12 to 14-year) exclusivity period.  On July 14, 2009, the Senate Health, Education, Labor and Pensions (HELP) Committee approved -- by a 16-7 vote -- an amendment providing a 12-year exclusivity period for biologic drug makers (see "Senators Hatch and Enzi Champion 12-Year Data Exclusivity in Senate").

In a statement released by the Biotechnology Industry Organization (BIO), BIO President and CEO Jim Greenwood observed that "[t]he strong bipartisan support in the Energy and Commerce Committee for a fair and balanced pathway for the approval of biosimilars is a decisive win for the patients of today and tomorrow," and contended that the Eshoo-Inslee-Barton amendment "strikes the appropriate balance among ensuring patient safety, expanding competition, reducing costs and providing necessary and fair incentives that will provide for continued biomedical innovation."  Mr. Greenwood noted that the amendments approved this month in both the House and Senate Committees had the support of the ALS Association, Alliance for Aging Research, Association of American Universities, National Venture Capital Association, AIDS Institute, National Minority AIDS Council, Children's Tumor Foundation, National Kidney Foundation, and Vietnam Veterans of America.

Comments

[Brittancus]

These politicians voted Against the Nathan Deal Amendment, that would Prevent Health Care Benefits to Illegal Aliens. Simply put--it's not their BLOODY MONEY! So what! Do they care if taxpayers have to foot the behemoth bill, for anybody who snubs our laws and enters a sovereign country called America? The nationwide parasites are --CHEAP LABOR--businesses who could care less, because they pile up enormous profits. The corporate hierarchy have been having a field day--FOR DECADES. A foreign national gets hurt, their service manager or whoever the underling is, drives the maimed person and relinquishes any responsibility by dumping them on the emergency hospital entranceway. BINGO! nothing to pay!

Perhaps Americans should find some old shoddy clothes, no shave, no haircut and enter every emergency room in our country in the millions? Speak a lot of gibberish and carry no identification with a small splinter in their finger, a touch of a fever or any minor condition. By federal law the hospital will have an emergency on a--EMERGENCY. I am afraid Americans have been Lemmings going over a proverbial cliff, since who knows when? We just keep paying and paying even more to the IRS, to support--ILLEGAL IMMIGRANTS. Try getting free health care in any other country, other than societies in the European Union? A FAT CHANCE! We are literary being taxed to death, to give welfare to the business overlords. These legislators have already tried to weaken E-Verify, local police action 287(g) and now unwinding the 1986 Simpson/Mazzoli enforcement law--which worked, but again was never enforced.

Even our Democrats who are trying to engineer health care for every American---INCLUDED 20 PLUS ILLEGAL IMMIGRANTS AND THEIR LARGE FAMILIES. Here are 29 Judas Iscariot's, who sold the American people out--for a lot more than 13 pieces of silver? HUNDREDS OF BILLIONS OF DOLLARS EVERY YEAR. Capps (D-CA), Eshoo (D-CA), Harman (D-CA), Matsui (D-CA), McNerney (D-CA), Waxman (D-CA), DeGette (D-CO), Murphy (D-CT), Castor (D-FL), Rush (D-IL), Schakowsky (D-IL), Braley (D-IA), Sarbanes (D-MD), Markey (D-MA), Dingell (D-MI), Stupak (D-MI), Pallone (D-NJ), Weiner (D-NY), Butterfield (D-NC), Space (D-OH), Sutton (D-OH), Doyle (D-PA), Gordon (D-TN), Gonzalez (D-TX), Green (D-TX),Welch (D-VT), Christensen (D-VI), Inslee (D-WA) and Baldwin (D-WI). I'm afraid I would be banned if I used the right epithet, when leaving a comment for these so called lawmakers?

These are the betrayers of--ALL--taxpayers. These 29 traitors gave illegal immigrants the right to pilfer your billfold and purse, while they sit in their Washington office collecting their 6 figure salaries. REMEMBER THEM AND THROW THEM OUT! DEMAND NO AMNESTY! NO FAMILY UNIFICATION KNOWN AS CHAIN MIGRATION! BUILD THE ORIGINAL FENCE! NO MORE HEALTH CARE OR ANY OTHER KIND OF BENEFITS FOR ILLEGAL IMMIGRANTS. CLOSE THE BORDER AND STATION THE NATIONAL GUARD. $2.5 TRILLION DOLLARS, JUST IN RETIREMENT BENEFITS? Learn uncorrupted facts at NUMBERSUSA. For myself and family! I am for any health care re-organization, as long as it doesn't smell of copious profiteering and corruption, like the majority of private insurers do?

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[jacksmith]

LEAD, FOLLOW, OR GET OUT OF THE WAY. (Thomas Paine)

We have the 37th worst quality of healthcare in the developed world. Conservative estimates are that over 120,000 of you dies each year in America from treatable illness that people in other developed countries don't die from. Rich, middle class, and poor a like. Insured and uninsured. Men, women, children, and babies. This is what being 37th in quality of healthcare means.

I know that many of you are angry and frustrated that REPUBLICANS! In congress are dragging their feet and trying to block TRUE healthcare reform. What republicans want is just a taxpayer bailout of the DISGRACEFUL GREED DRIVEN PRIVATE FOR PROFIT health insurance industry, and the DISGRACEFUL GREED DRIVEN PRIVATE FOR PROFIT healthcare industry. A trillion dollar taxpayer funded private health insurance bailout is all you really get without a robust government-run public option available on day one. Co-OP's ARE NOT A SUBSTITUTE FOR A GOVERNMENT-RUN PUBLIC OPTION. They are a fraud being pushed by the GREED DRIVEN PRIVATE FOR PROFIT health insurance industry that is KILLING YOU!

YOU CANT HAVE AN INSURANCE MANDATE WITHOUT A ROBUST PUBLIC OPTION. MANDATING PRIVATE FOR PROFIT HEALTH INSURANCE AS YOUR ONLY CHOICE WOULD BE A DISASTER AND UNETHICAL, CORRUPT, AND MORALLY REPUGNANT. AND PROBABLY UNCONSTITUTIONAL AS WELL.

These industries have been slaughtering you and your loved ones like cattle for decades for profit. Including members of congress and their families. These REPUBLICANS are FOOLS!

Republicans and their traitorous allies have been trying to make it look like it's President Obama's fault for the delays, and foot dragging. But I think you all know better than that. President Obama inherited one of the worst government catastrophes in American history from these REPUBLICANS! And President Obama has done a brilliant job of turning things around, and working his heart out for all of us.

But Republicans think you are just a bunch of stupid, idiot, cash cows with short memories. Just like they did under the Bush administration when they helped Bush and Cheney rape America and the rest of the World.

But you don't have to put up with that. And this is what you can do. The Republicans below will be up for reelection on November 2, 2010. Just a little over 13 months from now. And many of you will be able to vote early. So pick some names and tell their voters that their representatives (by name) are obstructing TRUE healthcare reform. And are sellouts to the insurance and medical lobbyist.

Ask them to contact their representatives and tell them that they are going to work to throw them out of office on November 2, 2010, if not before by impeachment, or recall elections. Doing this will give you something more to do to make things better in America. And it will make you feel better too.

There are many resources on the internet that can help you find people to call and contact. For example, many social networking sites can be searched by state, city, or University. Be inventive and creative. I can think of many ways to do this. But be nice. These are your neighbors. And most will want to help.

I know there are a few democrats that have been trying to obstruct TRUE healthcare reform too. But the main problem is the Bush Republicans. Removing them is the best thing tactically to do. On the other hand. If you can easily replace a democrat obstructionist with a supportive democrat, DO IT!

You have been AMAZING!!! my people. Don't loose heart. You knew it wasn't going to be easy saving the World. :-)

God Bless You

jacksmith — Working Class

I REST MY CASE (http://krugman.blogs.nytimes.com/2009/07/25/why-markets-cant-cure-healthcare/)

Republican Senators up for re-election in 2010.

* Richard Shelby of Alabama
* Lisa Murkowski of Alaska
* John McCain of Arizona
* Mel Martinez of Florida
* Johnny Isakson of Georgia
* Mike Crapo of Idaho
* Chuck Grassley of Iowa
* Sam Brownback of Kansas
* Jim Bunning of Kentucky
* David Vitter of Louisiana
* Kit Bond of Missouri
* Judd Gregg of New Hampshire
* Richard Burr of North Carolina
* George Voinovich of Ohio
* Tom Coburn of Oklahoma
* Jim DeMint of South Carolina
* John Thune of South Dakota
* Kay Bailey Hutchison of Texas
* Bob Bennett of Utah

[examiner]

How does exclusivity jive with patent term, i.e., is it completely independent and, if so, doesn't that make patents far less valuable given the extremely long clinical trial to approval process? In other words, while a patent holder may normally have, at most I would guess not more than 8 years term on their pioneering patent for their pioneering biological, why do they even need patents if they can simply say hey we've got at least 12 years monopoly from liscencing (I presume this means FDA approval)? Please tell me I'm not understanding something because my career depends on people needing patents!

[HealthCare Reform]

Either Obama is right and he can truly cut $500 billion of waste, fraud and abuse out the Medicare budget or Medicare dependent seniors must suffer when $500 billion is cut from muscle and bone because there really wasn’t that much fat.