By Robert Goldberg, Ph.D., co-founder, Center for Medicine in the Public Interest - 06/30/09 04:30 PM EDT
Known as follow-on biologics, or biosimilars, the FDA currently cannot approve these important medicines because of safety concerns over the difficulty in replicating these types of drugs.
On the other hand, Rep. Anna Eshoo (D-Calif.) believes her legislation should go through the standard process of committee markup and onto the House floor on its own, allowing for full vetting and debate on one of the key healthcare reforms of this generation.
Both pieces of legislation have their merits and both members should be commended for their willingness to take a lead on this important issue, but Eshoo’s bill has the right prescription for getting follow-on biologics to the market.
First, the Eshoo legislation puts a priority on patient safety by requiring appropriate and stringent clinical trials and testing. This is necessary because biologic drugs are created from living organisms such as proteins and carbohydrates, and are not as simple to replicate as traditional drugs like aspirin and antihistamines.
Second, by protecting adequate data exclusivity, innovator companies will not be forced to charge more for their biologic treatments.
Third, Eshoo’s legislation rewards new biologic innovation by drug companies because it grants them a longer period of data exclusivity to continue research and development to fight other diseases.
Fourth, Eshoo’s legislation gives hope to those suffering from rare diseases or conditions. If drug companies think they will have a short time before a generic version of their product is on the market, they will only focus on the drugs for major diseases and conditions, potentially ignoring ailments that are less common, but equally as serious, to those suffering.
Follow-on biologic legislation must be about balancing patient safety and cost reduction. To ignore either one — or to unnecessarily rush creating this pathway — will only hurt those patients who depend on follow-on biologics the most.
Barbour hardly GOP cure
From Mike Maynard
Cheri Jacobus might as well as have included her résumé along with her glowing tribute to Mississippi Gov. Haley Barbour, the new head of the Republican Governors Association (“Welcome back, Barbour,” June 26). Her column just begs for a response.
Let’s see: What’s wrong with the picture? A white, Southern, politically connected, former inside-the-Beltway lobbyist who’s way over there on the right-hand side of the ideological spectrum. Not a good recipe for a candidate at a time when the Republican “brand” as currently constituted is held in such low regard.
Barbour is all those things, needless to say, in addition to being a governor. That would be the same governor who’s still trying to explain away the allocation of post-Katrina reconstruction funds at his disposal. Could it be that he kowtowed to casino owners ahead of ordinary Mississippians? Just asking.
He’s also a former RNC chairman, as though that’s somehow a virtue these days. Barbour’s still tainted by a little trip he made, ostensibly on the RNC’s dime, back in 1994. Was it really necessary that he go all the way to Hong Kong to solicit a big-bucks campaign loan? I know appearances can be deceiving and these things always need to be placed in the proper context, and what he did may have been legal. But I remember one word immediately springing to mind when I read about Haley’s excellent Hong Kong adventure: sleazy.
Barbour part of a “deep bench” for the 2012 primaries? At Obama HQ, they must be licking their chops at the prospect for a Barbour candidacy.
From Yeh Ling-Ling, executive director, Alliance for a Sustainable USA
I feel compelled to warn U.S.-born citizens and legal immigrants concerned about unemployment after reading your article “Obama extends immigration reform time-frame, but skepticism remains” (June 26).
If adopted, the misnamed “comprehensive” immigration reform — granting amnesty to 12 million or more people and massive guest-worker visas — being pushed by promoters of mass immigration, will lead to an explosion of legal and illegal immigration. With millions of adults becoming potential voters, it is highly improbable that the Obama administration or the next will ensure that people who enter the U.S. illegally or “guest workers” who have violated their immigration status will be deported.
Furthermore, many legalized people and “guest workers” will have children born here, and once naturalized can bring in their extended families, who will become potential voters. Those newcomers, white and non-white, will also be jobseekers and people needing healthcare, education and other very expensive social services.
Decades ago, China understood that population growth would impede its economic success. It has seriously restricted immigration even for people of Chinese descent. When will Americans follow suit?
From Wes Pedersen
Dick Cheney needs a title for the book he’s writing. Eight Years as the Dungeon Master at the White House comes to mind.
Chevy Chase, Md.