The President's FY 2010 Budget for FDA request is $3.2 billion -- a 19% increase from FY 2009. Mostly it’s more money spent the right way.
Mostly.
Let’s look at the numbers.
* The FY 2010 request includes increases of $295.2 million in budget authority and $215.4 million in industry user fees. It includes increases for current law user fees and for infrastructure to support critical agency operations.
* The FDA proposes four new user fees to facilitate Protecting America’s Food Supply ($259.3 million) via the registration and inspection of food manufacturing and processing facilities. (They’ll be a hue and cry over this one); the re-inspection of facilities that fail to meet Good Manufacturing Practices and other safety requirements. (Grime doesn’t pay); the issuing of export certifications for food and feed. (Don’t have a cow).
* Safer Medical Products ($166.4 million) – This effort provides targeted resources to improve the safety of human and animal drugs, medical devices, vaccines, blood, and other medical products. It will allow the FDA to strengthen safety and security of the supply chain for medical products. The initiative also includes $46.6 million in new user fees for generic drug review. (It’s about time).
* Current Law User Fees ($74.4 million) – In addition to the new user fees proposed for FY 2010, the FDA request also includes inflationary and other authorized increases for fees that support FDA review of applications for new human drugs (+$67.5 million), animal drugs (+$2.3 million), and medical devices (+$4.5 million). Mazel tov – but still not enough.
* Follow-on Biologics – The budget proposes a new authority for the FDA to approve follow-on biologics through a regulatory pathway that protects patient safety and promotes innovation. (Nobody said FOBs were going to be easy – or inexpensive to produce.)
So far so good – but here’s the big mistake:
* Drug Importation -- $5 million for the FDA to develop policies to allow Americans to buy drugs approved in other countries.
Here we go again. $5 million down the toilet just to placate the lunatic fringe.
State and local importation schemes have been dismal and politically embarrassing. Remember Illinois’ high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population.
And what of Minnesota’s RxConnect? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.
Remember Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield has been out of “drugs from Canada business” since August 2006. (But that hasn’t stopped Chris Collins – a representative of CanaRX from telling some New York municipalities that, “We’re now saving over $2 million a year in Springfield, MA."
Shameful.
This is particularly appalling since the drugs being sent to U.S. customers from CanaRX are most certainly not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. CanaRX – by their own admission – sources their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.
PS/ The drugs CanaRX sells to Americans aren’t even legal for sale in Canada.
And, speaking of tea parties, according to a story in the Boston Globe, “Four years after Mayor Thomas M. Menino bucked federal regulators and made Boston the biggest city nationally to offer low-cost Canadian prescription drugs to employees and retirees, the program has fizzled, never having attracted more than a few dozen participants.”
In late July of 2008, the Canadian supplier for the program, Winnipeg-based Total Care Pharmacy, sent a letter to city officials saying the firm was terminating its agreement because there were so few participants. In 2006, Boston saved $4,300 on a total of 73 prescriptions. When Total Care decided to end its relationship with the city, only 16 Boston retirees were still participating.
And such programs won’t do any better on a national basis. A study by the non-partisan federal Congressional Budget Office (CBO) showed that importation would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the tens of millions of dollars the FDA would need to oversee drug safety for the dozen or so nations generally mentioned in foreign drug importation schemes.
That’s millions of dollars in addition to the $5 million in the President’s budget proposal.
This is not the pathway to safer drugs. In fact, it’s precisely the opposite.
What drug importation does present is the opportunity to import de facto price controls. Is this the President’s agenda? It certainly has been for his Chief of Staff, Rahm Emanuel, during his tenure as the Congressman from Blagojevich-ville.
In order to combat this back-door to the eradication of intellectual property rights, innovator pharmaceutical companies would likely restrict their sales of medicines to foreign nations to a certain fixed amount. This is precisely what some threatened to do when Canadian pharmacies began selling medicines designated for their domestic market to Americans.
In 2003, upset by this logical strategy to protect their intellectual property, Minnesota’s then-Attorney General Mike Hatch, thumped his chest and announced the state’s intention to sue drug companies for their attempts to keep drugs earmarked for sales in Canada in Canada. Mr. Hatch’s announcement got a lot of news coverage and garnered him a prominent speaking engagement in front of the Families USA national conference in Washington, DC (after me and before Senator Ted Kennedy). What got hardly any coverage was the ensuing decision by a Federal judge who dismissed the case, “Denied as Moot.”
Mr. President, please review Surgeon General Richard Carmona’s report on the issues relative to drug importation. That report can be found here.
$5 million to study drug importation? Money for nothing.
Mostly.
Let’s look at the numbers.
* The FY 2010 request includes increases of $295.2 million in budget authority and $215.4 million in industry user fees. It includes increases for current law user fees and for infrastructure to support critical agency operations.
* The FDA proposes four new user fees to facilitate Protecting America’s Food Supply ($259.3 million) via the registration and inspection of food manufacturing and processing facilities. (They’ll be a hue and cry over this one); the re-inspection of facilities that fail to meet Good Manufacturing Practices and other safety requirements. (Grime doesn’t pay); the issuing of export certifications for food and feed. (Don’t have a cow).
* Safer Medical Products ($166.4 million) – This effort provides targeted resources to improve the safety of human and animal drugs, medical devices, vaccines, blood, and other medical products. It will allow the FDA to strengthen safety and security of the supply chain for medical products. The initiative also includes $46.6 million in new user fees for generic drug review. (It’s about time).
* Current Law User Fees ($74.4 million) – In addition to the new user fees proposed for FY 2010, the FDA request also includes inflationary and other authorized increases for fees that support FDA review of applications for new human drugs (+$67.5 million), animal drugs (+$2.3 million), and medical devices (+$4.5 million). Mazel tov – but still not enough.
* Follow-on Biologics – The budget proposes a new authority for the FDA to approve follow-on biologics through a regulatory pathway that protects patient safety and promotes innovation. (Nobody said FOBs were going to be easy – or inexpensive to produce.)
So far so good – but here’s the big mistake:
* Drug Importation -- $5 million for the FDA to develop policies to allow Americans to buy drugs approved in other countries.
Here we go again. $5 million down the toilet just to placate the lunatic fringe.
State and local importation schemes have been dismal and politically embarrassing. Remember Illinois’ high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population.
And what of Minnesota’s RxConnect? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.
Remember Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield has been out of “drugs from Canada business” since August 2006. (But that hasn’t stopped Chris Collins – a representative of CanaRX from telling some New York municipalities that, “We’re now saving over $2 million a year in Springfield, MA."
Shameful.
This is particularly appalling since the drugs being sent to U.S. customers from CanaRX are most certainly not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. CanaRX – by their own admission – sources their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.
PS/ The drugs CanaRX sells to Americans aren’t even legal for sale in Canada.
And, speaking of tea parties, according to a story in the Boston Globe, “Four years after Mayor Thomas M. Menino bucked federal regulators and made Boston the biggest city nationally to offer low-cost Canadian prescription drugs to employees and retirees, the program has fizzled, never having attracted more than a few dozen participants.”
In late July of 2008, the Canadian supplier for the program, Winnipeg-based Total Care Pharmacy, sent a letter to city officials saying the firm was terminating its agreement because there were so few participants. In 2006, Boston saved $4,300 on a total of 73 prescriptions. When Total Care decided to end its relationship with the city, only 16 Boston retirees were still participating.
And such programs won’t do any better on a national basis. A study by the non-partisan federal Congressional Budget Office (CBO) showed that importation would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the tens of millions of dollars the FDA would need to oversee drug safety for the dozen or so nations generally mentioned in foreign drug importation schemes.
That’s millions of dollars in addition to the $5 million in the President’s budget proposal.
This is not the pathway to safer drugs. In fact, it’s precisely the opposite.
What drug importation does present is the opportunity to import de facto price controls. Is this the President’s agenda? It certainly has been for his Chief of Staff, Rahm Emanuel, during his tenure as the Congressman from Blagojevich-ville.
In order to combat this back-door to the eradication of intellectual property rights, innovator pharmaceutical companies would likely restrict their sales of medicines to foreign nations to a certain fixed amount. This is precisely what some threatened to do when Canadian pharmacies began selling medicines designated for their domestic market to Americans.
In 2003, upset by this logical strategy to protect their intellectual property, Minnesota’s then-Attorney General Mike Hatch, thumped his chest and announced the state’s intention to sue drug companies for their attempts to keep drugs earmarked for sales in Canada in Canada. Mr. Hatch’s announcement got a lot of news coverage and garnered him a prominent speaking engagement in front of the Families USA national conference in Washington, DC (after me and before Senator Ted Kennedy). What got hardly any coverage was the ensuing decision by a Federal judge who dismissed the case, “Denied as Moot.”
Mr. President, please review Surgeon General Richard Carmona’s report on the issues relative to drug importation. That report can be found here.
$5 million to study drug importation? Money for nothing.
