Mr. President, I support the effort to provide prescription drugs to Medicare beneficiaries and to lower the costs of medicines for all Americans. Today's therapies are too valuable, in terms of improving health and quality of life, for…
Mr. President, I support the effort to provide prescription drugs to Medicare beneficiaries and to lower the costs of medicines for all Americans. Today's therapies are too valuable, in terms of improving health and quality of life, for Medicare beneficiaries not to have prescription drug coverage.
However, we must not create new opportunities for counterfeit products, or products that have been tampered with, or products of unknown origin to be brought into this country.
The amendment I have offered requires the Secretary of Health and Human Services to certify that the reimportation of drug products will pose no additional risk to the public health and safety and will result in a significant reduction in the cost of covered products to the American consumer.
If reimportation is safe and will reduce costs, this amendment should not pose a problem. However, these are genuine concerns that reimportation may not be safe for Americans.
We have had this issue before the Senate on two previous occasions. Three years ago during consideration of the annual appropriations bill for the Department of Agriculture, Food and Drug Administration and related agencies, a similar amendment was added to the bill. The Senate unanimously approved that amendment.
Then again last July, when we were considering the Greater Access to Pharmaceuticals Act, a similar amendment was offered that limited reimportation to products from Canada. Again, the Senate, by a vote of 99-0 approved this safeguard as part of the legislation that passed the Senate. The House did not act upon this legislation.
In both these cases the Senate has adopted this amendment by a unanimous vote both times for an obvious reason: the safety of the American consumer must be protected.
Three years ago, Secretary of HHS Donna Shalala was not able to make such a demonstration as required by that law.
I ask unanimous consent that a copy of her letter to President Clinton dated December 26, 2000, be printed in the Record.
Mr. President, on July 9, 2001, a letter from the current Secretary of Health and Human Services, Tommy Thompson, indicated that based on an analysis by the Food and Drug Administration on the safety issues and analysis by his planning office on the cost issues, he could not make the required determinations, and he stated his view that we should not sacrifice public safety for uncertain and speculative cost savings.
Secretary Thompson also indicated that prescription drug safety could not be adequately guaranteed if drug reimportation were allowed and that costs associated with documentation, sampling, and testing of imported drugs would make it difficult for consumers to get any significant price savings.
I ask unanimous consent that Secretary Thompson's letter be printed in the Record.
Mr. President, just this week, Mark McClellan, Commissioner of the Food and Drug Administration, has written to reiterate this point. I ask unanimous consent that Dr. McClellan's letter of June 19, 2003 be printed in the Record.
Mr. President, it would seem prudent that the safeguards we have adopted twice, by unanimous votes, should also be applied to
this proposal. That is why I offer this amendment.
We should be certain that any change we make results in no less protection in terms of the safety of the drugs supplied to the American people and will indeed make prescription drugs more affordable. Liberalization of protections that are designed to keep unsafe drugs out of this country, especially considering the terrorist threats we face now, should occur only if the necessary safeguards are in place.
This amendment will ensure that the concerns of the last two administrations regarding the safety and cost-effectiveness are addressed prior to the implementation of this proposal.
Currently, under the Federal Food, Drug, and Cosmetic Act, it is unlawful for anyone to introduce into interstate commerce a new drug that is not covered by an approved new drug application or an abbreviated new drug application. Approval must be sought on a manufacturer and product-by-product basis. A product that does not comply with an approved application, including an imported drug not approved by FDA for marketing in the United States, may not be imported, even if approved for sale by that country.
A product introduced into interstate commerce that does not comply with an approved application is considered an unapproved new drug in violation of the Food, Drug, and Cosmetic Act, as well as ``misbranded'' under the section of that act.
Under section 801 of the act, a drug that is manufactured in the United States pursuant to an approved new drug application and shipped to another country may not be reimported into the United States by anyone other than the original manufacturer. This prohibition on reimportation of products previously manufactured in the United States and then exported was added in 1988 to prevent the entry into this country of counterfeit and adulterated products.
Section 801 was enacted not to protect the corporate interests of pharmaceutical companies but to protect the safety of American consumers. Counterfeit drugs are a very real threat and can be deadly. Any change of drug reimportation laws must assure safety from this threat. Limiting reimportation to drugs from Canada does not necessarily solve that problem.
In a July 11, 2001, letter to the Energy and Commerce chairman and ranking member, William Simpkins, Acting Administrator of the Department of Justice Drug Enforcement Administration, who was referring to reimportation amendments, said the following:
(W)e oppose . . . these amendments because they would
hinder the ability of law enforcement officials to ensure
that drugs are imported into the United States in compliance
with long-standing Federal laws designed to protect the
public health and safety.
More recently, in letter dated November 25, 2002, Asa Hutchinson, then Administrator of the Drug Enforcement Administration at the US Department of Justice, reiterated this position with respect to any type of proposal that might limit the ability of the FDA to inspect and assure the safety and compliance with Federal law of products that would be brought back into the United States.
I ask unanimous consent that Administrator Hutchinson's letter be printed in the Record.
Mr. President, William Hubbard, FDA's Associate Commissioner for Policy and Planning, and the FDA's authority on the topic of reimportation of pharmaceuticals, has testified a number of times before Congress regarding the dangers of reimported products and the inability of the U.S. regulatory system to assure the safety of products brought into this country. Most recently, this month before the House Committee on Government Reform, Dr. Hubbard testified
(T)he overall quality of drug products that consumers
purchase from United States pharmacies is very high. The
public can be confident that the drugs they use are safe and
effective. However, FDA cannot offer the same assurances to
the public about the safety of drugs they buy from foreign
sources.
There are a number of reasons why these products are not safe. Counterfeiting of drugs is common throughout the world and the transshipment of these counterfeit products through Canada is one of the most serious dangers.
A recent example of the dangers of counterfeiting is the FDA alert issue on May 23 of this year regarding counterfeit version of the cholesterol lowering agent, Lipitor. This product is taken by over 18 million Americans. This investigation is currently ongoing and FDA is still trying to determine the extent of this case.
In March, the FDA discovered counterfeit versions of the drug Procrit which had been contaminated with bacteria or in some cases the product contained no active ingredient.
There are numerous other examples. It is amazing the number of drugs that are now on the shelves in drugstores in America that are counterfeit and no one knows about it. These are difficulties that we now face. The proposal of this amendment by the Senator from North Dakota will further relax our capability to find illegal drugs, and to find those drugs that are dangerous
that are being brought into this country.
It will create a new opportunity for transshipping drugs from all over the world into our country which will be a great danger to the citizens of our country.
The National Association of Boards of Pharmacy, the body that represents the state boards of pharmacy in all 50 United States, as well as eight Canadian Provinces has stated in March of this year
Of utmost concern is the lack of ability to determine the
actual country of origin. An order for what is purported to
be a Canadian drug may never be filled by a legitimate
Canadian pharmacy with a Canadian drug or even be filled in
Canada.
NABP, representing the boards that regulate the practice of pharmacy, has also recently joined the Canadian National Association of Pharmacy Regulatory Authorities in endorsing a statement opposing illegal importation of prescription drugs.
The Canadian government itself has stated publicly that drug products shipped to Canada for resale in other countries do not fall under the Canadian regulatory system, and they can provide no assurance as to the safety or authenticity of such drugs.
The conditions contained in my amendment, which would be added to the legislative proposal before the body, are the same as those previously adopted twice by this Senate. They were adopted both times by unanimous votes of the Senate.
I ask my colleagues to again support this amendment.