A new law intended to make it easier for Texans to buy low-cost prescription drugs from Canada was put on hold just weeks before it was to go into effect, when the federal government pointed out the measure was illegal.
Texas Attorney General Greg Abbott (R) caused implementation of the law to be postponed August 31 in response to a complaint from the U.S. Food and Drug Administration (FDA). FDA officials said the drug provision, part of a broader law reauthorizing the Texas State Board of Pharmacy, violated federal law governing drug imports. The board is currently drafting measures to satisfy the requirements of the law but will not enact them until Abbott approves them.
Senate Bill 410, enacted by the state legislature and signed by Gov. Rick Perry (R) on June 18, in part “requires the Texas State Board of Pharmacy (TSBP) to inspect and authorize Canadian pharmacies to import prescription medications into the State of Texas,” according to the TSBP Web site.
The Web site explanation of the bill continues, “The law requires that the Board designate from one to ten Canadian pharmacies as having passed inspection, and thus allow the pharmacies to ship prescription drugs into Texas. The Board is also mandated to provide information on these pharmacies on its website to facilitate ordering of drugs by Texas residents.”
FDA: Importation Is Illegal
On June 17, the TSBP received a letter from the FDA indicating the portions of S.B. 410 dealing with Canadian pharmacies are in violation of federal law.
The letter, also addressed to Perry, was written by Randall W. Lutter, acting associate commissioner for policy and planning for public health service of the FDA. Lutter pointed out, “Congress enacted these provisions to create a relatively ‘closed’ drug distribution system, which helps ensure that the domestic drug supply is safe and effective. Accordingly, if an entity or person were to import prescription drugs into the State of Texas from Canada, that importation would violate the Federal Food, Drug, and Cosmetic Act (FFDCA) in virtually every instance. This is true even if the proposed Texas legislation purports to legalize the conduct under state law.”
Law Evaded Federal Safeguards
Lutter noted virtually all prescription drugs imported for personal use into the United States from Canada violate the FFDCA because they are unapproved new drugs, labeled incorrectly, or dispensed without a valid prescription.
“FDA approvals are manufacturer-specific, product-specific, and include many requirements relating to the product,” Lutter continued, “such as manufacturing location, formulation, source and specifications of active ingredients, processing methods, manufacturing controls, packaging location, container/closure system, and appearance.
“Generally, drugs sold outside of the United States are not manufactured or packaged by a firm that has FDA approval for that drug. Moreover, even if the manufacturer has FDA approval for a drug, the version produced for foreign markets usually does not meet all of the requirements of the United States approval, and thus is unapproved.”
On June 23, the TSBP requested an opinion from the Texas attorney general as to whether federal law preempts the relevant sections of S.B. 410 and, therefore, precludes implementation of the law by the board. The TSBP’s executive director/secretary, Gay Dodson, also requested an opinion on the related question of whether it is a violation of federal law for the board to authorize and promote the importation of pharmaceuticals from Canada.
Abbott is expected to rule later this year.
Supporters: Everybody’s Doing It
Rep. Scott Hochberg (D-Houston), sponsor of S.B. 410, said the drug importation provision doesn’t violate federal law and would help promote health and safety standards, according to an August 31 article in the Houston Chronicle.
“States clearly have the right and responsibility to protect the health and safety of their residents, and Texas has a compelling interest to inspect Canadian pharmacies as long as they continue to solicit drug sales to Texans,” Hochberg said in a letter to the attorney general.
Hochberg said other states have programs that go further than the Texas law by actually licensing foreign pharmacies, but those states haven’t been sued by the federal government. Hochberg said at least nine other states and the District of Columbia have Web sites providing information on Canadian pharmacies, as his bill proposes.
“The fact that Rep. Hochberg thinks it must be OK because other states have passed even more flagrant violations doesn’t make it legal; the FDA has warned those states also,” said Merrill Matthews, resident scholar at the Lewisville, Texas-based Institute for Policy Innovation and director of the Council for Affordable Health Insurance. “To put it another way, driving 75 mph on a posted 65 mph highway isn’t legal just because others may be driving 80.
“The Texas attorney general is doing exactly the right thing,” Matthews said. “It is very clear that the Texas importation law flagrantly ignored federal law and FDA warnings.”
Susan Konig ([email protected]) is managing editor of Health Care News.
For more information …
Nearly 100 documents on prescription drug importation are available through PolicyBot™, The Heartland Institute’s free online research database. Point your Web browser to http://www.heartland.org, click on the PolicyBot™ button, and select the topic/subtopic combination Health Care/Drugs: Importation.