Gregg-Smith Myths versus Bipartisan Facts
Gregg-Smith Myth #1: The bipartisan drug importation bill sponsored by Senators Dorgan, Snowe, Kennedy, McCain and many others: “Allows importation of potentially hazardous unapproved prescription drugs.”
Bipartisan Fact: Only FDA-approved drugs may be imported under the bipartisan drug importation bill. In fact, only the bipartisan bill provides a way for FDA and importers to know which drugs in distribution in other countries are FDA-approved.
Gregg-Smith Myth #2: The bipartisan drug importation bill: “Permits the importation of drug products with a different active ingredient, a related active ingredient, or different active ingredients.”
Bipartisan Fact: When, to avoid importation, a drug company stops distributing an FDA-approved drug in other countries and instead distributes a drug with an active ingredient that differs slightly from the active ingredient in the FDA-approved drug but would be expected to act in the same way in the body, the bipartisan drug bill requires the company to seek approval of the non-FDA approved drug. That drug can only be imported if FDA approves the drug because it is safe and effective.
Gregg-Smith Myth #3: The bipartisan drug importation bill: “For personal importation, FDA may waive virtually any potential approval condition, including whether the drug is FDA-approved or manufactured in an FDA-inspected facility.”
Bipartisan Fact: Under the bipartisan bill, drugs imported through the mail by individuals from Canadian pharmacies must be fully-FDA approved. The sponsors of the bipartisan bill intend that drugs personally carried by individuals from Canada must also be FDA-approved and dispensed with a prescription. Both the bipartisan bill and the Gregg-Smith bill preserve FDA’s discretion to allow personal imports of unapproved drugs to continue treatment of serious illnesses.
Gregg-Smith Myth #4: The bipartisan drug importation bill: “Permits the importation of certain biological products approved under section 505, such as insulin and growth hormone.”
Bipartisan Fact: The bipartisan drug bill prohibits the importation of any biological product. It also prohibits the importation of injected drugs. Insulin and growth hormone are both biological products that are injected. They cannot be imported under the bipartisan bill.
Gregg-Smith Myth #5: The bipartisan drug importation bill: “Lacks critical safety provisions. Has only the barest provisions to protect American consumers from rogue Internet pharmacies; does not allow FDA to restrict ports of entry or to require importers to provide advance notice of any shipment to ensure that all incoming commercial drug shipments are inspected.”
Bipartisan Fact: Under the bipartisan bill, only Canadian pharmacies registered and approved and regularly inspected by FDA, will be able to export drugs to individuals. The source of these drugs will be documented by a drug pedigree. Anti-counterfeiting markers, or other technologies, will enable Customs and FDA officials to identify permitted drugs at the border. Any package without a valid marker may be confiscated and destroyed. Prior notice of, or restricting ports of entry for, shipments from Canada to individuals will not be necessary. The Gregg-Smith bill also does not require prior notice of shipments from Internet pharmacies to individuals, and it does not require that such shipments be marked.
Gregg-Smith Myth #6: The bipartisan drug importation bill: “Automatically permits importation from 19 countries beyond Canada without prior FDA review-even if the FDA has evidence of harm to American consumers.”
Bipartisan Fact: The Gregg-Smith bill applies the now discredited certification requirement for expanding drug imports beyond Canada that is currently used to deny access to safe, imported drugs. Requiring FDA to find that importation from European countries is safe, as Gregg-Smith does, is a guarantee that there will be no importation.
By contrast, the bipartisan bill provides strong assurance of the safety of imported drugs by requiring that they are FDA-approved and accompanied by a chain of custody verifying that the drugs were produced in an FDA-inspected manufacturing plant. One year after enactment, the bipartisan bill allows U.S. wholesalers and pharmacies to commercially import drugs from 19 countries: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Spain, Sweden, The Netherlands, the United Kingdom, Australia, New Zealand, Japan, and Switzerland, all countries with well-developed systems for the regulation of prescription drugs.
Gregg-Smith Myth #7: The bipartisan drug importation bill: “Unworkable and constitutionally questionable ‘forced sales’ provisions. Requires drug manufacturers to sell unlimited quantities of their drugs to foreign retailers at whatever price that foreign country stipulates, likely violating both the Taking Clause of the Fifth Amendment and the Patent Clause of Article I of the U.S. Constitution.”
Bipartisan Fact: Under the bipartisan bill, if a drug company chooses to sell prescription drugs in a foreign country at the prices in that country, the company can’t discriminate against firms that import to the U.S. from that country. To be effective, a drug import bill must include such a provision. That’s because big drug companies have cut off Canadian pharmacies that import drugs to individuals in the U.S. Drug industry attorneys always say that legislation to cut the cost of drugs for consumers violates the Constitution, but objective legal authorities say the bipartisan bill is constitutional.
In addition, the Gregg-Smith bill assumes that, if the drug companies stop supplying Canadian pharmacies that send drugs to the U.S., the Canadian pharmacies can instead export to the U.S. drugs that they have gotten from Europe. As the Canadian International Pharmacy Association, explains, however: “It can never happen. Under Canadian law, specifically the Food and Drugs Act, it is illegal for a pharmacist or wholesaler to trans-ship drugs in finished dosage form from a foreign country into Canada even if it is designated for export only.” And even if trans-shipment were permitted by Canada, the Gregg-Smith bill does nothing to stop drug companies from discriminating against European distributors that would send drugs to Canada. That’s why there will be no drug imports under the Gregg-Smith bill.
Gregg-Smith Myth #8: The bipartisan drug importation bill: “Provides inadequate resources to the FDA and will likely divert funds from other critical domestic drug review and enforcement activities. Not only are foreign wholesalers & exporters exempt from having to pay any user fees, but the arbitrary 1% cap means that the current $1 billion worth of drugs imported annually from Canada would generate a mere $10 million in FDA resources.”
Bipartisan Fact: About 40 Canadian pharmacies currently supply most of the $1 billion of drugs now imported from Canada annually. Total user fees capped at $10 million means user fees per pharmacy of up to $250,000, enough to pay for an FDA inspector on-site full-time at each of these pharmacies! The 1 percent cap will be adequate and can be adjusted based on technical input from FDA, if necessary. By contrast, the uncapped fee in the Gregg-Smith bill invites FDA to set fees unnecessarily high-creating yet another barrier to drug importation-so that it won’t be cost-effective to import drugs and consumers won’t actually save money.
Gregg-Smith Myth #9: The bipartisan drug importation bill: “Unworkable time-frame jeopardizes the safety of American consumers. FDA must develop, implement, collect user fees, and conduct inspections to permit the importation of drugs from Canada within 90 days and from 19 other countries within a mere 12 months.”
Bipartisan Fact: The bipartisan bill provides a clear framework for FDA to allow safe importation of drugs from Canada within 90 days. Under the bipartisan bill, drugs may be imported only if FDA knows that the drugs meet the conditions of FDA-approval, and FDA is given resources immediately to review imported drugs. Although a $10,000 licensing fee is collected up front, ongoing user fees from Canadian pharmacies and domestic wholesalers and pharmacies are first due after six months. Importation from Canada will not work at all under the Gregg-Smith bill because drug companies will cut-off supplies to participating Canadian pharmacies and wholesalers, and importation will never expand to other countries because FDA refuses to certify that importation is safe.
Gregg-Smith Myth #10: The bipartisan drug importation bill: “Imposes unreasonably higher burdens on U.S. pharmacies, while leaving foreign wholesalers & exporters largely unregulated. Registration requirements apply only to U.S. wholesalers and U.S. and Canadian pharmacies; wholesalers & exporters from Canada & the other 19 countries are not required to register or confirm in advance their credentials for exporting large quantities of drugs to the U.S.”
Bipartisan Fact: Under the bipartisan bill, FDA will have the authority regularly to inspect suppliers of drugs in other countries to verify that the drugs are sourced from FDA-approved plants and that they are handled and stored properly. FDA must approve registrations only if they satisfy registration conditions, including how drugs are sourced to FDA-inspected plants. By contrast, although the Gregg-Smith bill requires Internet pharmacies to have an approved license, others that simply submit some information to FDA are automatically registered.
Gregg-Smith Myth #11: The bipartisan drug importation bill: “Forces Canadian pharmacies to cut off their supply or increase prices for American consumers. High financial obligations ($10,000 user fee, semiannual inspection fees) and unreasonably intrusive operational requirements (record and facility inspections as often as every day) will compel most Canadian pharmacies to restrict sales to American consumers.”
Bipartisan Fact: About 40 Canadian pharmacies currently supply most of the $1 billion of drugs now imported from Canada annually. The volume of business for these pharmacies will easily be able to support the $10,000 registration fee and the inspection fee under the bipartisan bill. Additionally, the bipartisan bill ensures these pharmacies will actually have drugs supplies to send to U.S. consumers because the drug companies won’t be able to discriminate against Canadian pharmacies that export to the United States. Under the Gregg-Smith bill, by contrast, drug companies will be able to cut off supply to these Canadian pharmacies, preventing U.S. consumers from achieving any savings.
The frequent inspections required under the bipartisan bill will ensure that Canadian pharmacies dispense only FDA-approved drugs, accompanied by a prescription, and after a pharmacist has checked for potential interactions with other drugs taken by the patient. By contrast, under the Gregg-Smith bill, FDA may only inspect records if FDA has “reason to believe” that an imported drug “presents a risk to public health.”
Gregg-Smith Myth #12: The bipartisan drug importation bill: “Fails to provide important information to American consumers. Allows imported drugs to be mixed with domestic drugs, and does not require that imported drugs be labeled as such.”
Bipartisan Fact: The bipartisan bill requires that a pedigree accompany any imported drug to the pharmacy level. Drugs will not be commingled. The sponsors of the bipartisan bill agree that consumers should know if they are dispensed imported drugs and have drafted a modification to require such labeling when imported drugs are dispensed at retail pharmacies.
Gregg-Smith Myth #13: The bipartisan drug importation bill: “Will increase drug costs and slow down approval of new medicines here in the U.S. Requiring the FDA to review foreign-intended drugs will take time & resources that could otherwise go to reviewing new medicines intended for the U.S. market. Additionally, manufacturers would likely pass on the cost of these applications on the American consumer in the form of higher drug prices.”
Bipartisan Fact: The bipartisan bill requires drug companies to tell FDA if the drugs they distribute overseas are the same as or different than the FDA-approved drugs they distribute domestically. Most likely, foreign drugs will not be different, but when they are, or when the drug companies change their foreign drugs to thwart importation, FDA will review and may approve the differences. FDA will receive additional user fees when it approves these differences, so this process will not burden FDA’s review of new drugs. Drug companies are more likely to cut their prices to compete with the price of drugs imported under the bipartisan bill.
Call your senators today. ask them to sponsor and support S2328.
Write them at Senate.gov
Or call them via the Senate switchboard: (202) 224-3121
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