FDA Clarifies Importation Law As Internet Pharmacies Proliferate
Also proliferating are groups advocating and promoting cross-border access for U.S. consumers to affordable prescription drugs via Internet and mail-order pharmacies.
One newly formed group, the NorthAmerican-Pharmotherapeutic Consultants Association (NA-PCA)a Vermont-based professional organization of Canadian, Mexican, and American physicians and pharmacistshas initiated an accreditation program. The program is run by NA-PCAs Internet and Mailorder Pharmacy Accreditation Commission (IMPAC), which developed the programs quality assurance standards.
Dana Noble, a Massachusetts nurse and NA-PCAs acting executive director, said the IMPAC accreditation program will help North American consumers identify legitimate Internet and mail-order pharmacies.
NA-PCA is charging $35,000 for a two-year accreditation term, she added.
But Thomas McGinnis, FDAs pharmacy affairs director, said that the Food, Drug, and Cosmetics Act (FDCA) is clear: When Canadian or other foreign Internet and mail-order pharmacies ship prescription drug products to patients in the United States, those companies are violating the law.
Drugs with FDA-approved labeling that are manufactured in the United States and exported to other countries, including Canada, he added, may not be reimported by anyone other than the manufacturer.
The United States Customs Service each year stops thousands of packages of prescription drug products from entering the country, McGinnis said.
FDA issues notices to addressees of the packages that are held and provides opportunities for people to explain why their parcel should be allowed entry into the United States, he said. If FDA does not hear from an addressee, the package is returned to the mail-order pharmacy.
Reuters reported in March that one Canadian company, LePharmacy.com, advises its customers to ignore FDA notices and reorder a prescription if a package is held by customs.
FDA has kept a close watch on foreign Internet and mail-order pharmacies in recent years and has issued several warning letters to companies that appear to be engaged in illegally shipping drug products to patients in the United States, McGinnis said.
The agency turned to the Internet in 2000 to electronically issue warning notices, known as cyber letters, to foreign Web-site operators informing them that their activities of marketing drugs products for sale and distribution to people in the United States may be illegal.
Quality. William K. Hubbard, FDAs associate commissioner for policy and planning, in a February 12 letter responding to questions about FDA policy posed by Louisiana attorney Robert P. Lombardi, said that, for public health reasons, FDA is very concerned about the importation of prescription drugs from Canada.
In the agencys experience, Hubbard noted, many drug products obtained from foreign sources that purport and appear to be the same as pharmaceuticals marketed in the United States have been of unknown quality.
We cannot provide adequate assurance to the American public that the drug products delivered to consumers in the United States from foreign countries are the same products approved by FDA, Hubbard said.
Henri R. Manasse Jr., executive vice president for the American Society of Health-System Pharmacists, said that the practice of illegal importation of drug products by Internet and mail-order pharmacies threatens the integrity of the drug supply in the United States.
Many foreign countries, he noted, lack quality control for their drug manufacturing and shipping practices.
How do we assure that there are not adulterations of drug products sold by foreign-based Internet and mail-order pharmacies, he asked. These are the same issues this country wrestled with in 1820 when the United States Pharmacopeia was established. It is history repeating itself. There are intense market forces that are crashing in on the integrity of a system that many of us have spent a lot of time to keep together and keep together well. Are we willing to risk the integrity of our system for economic gains?
FDAs McGinnis said that about 210 countries make drug products. One third of those nations have good regulatory controls in place, another third have regulatory controls but lack enforcement, and the bottom third have no regulatory controls.
Scare tactic. But NA-PCAs Noble argued that FDA has not provided clear evidence that drugs purchased by U.S. consumers from Canadian pharmacies have harmed patients. FDA, she added, has used the issue of uncertain quality as a scare tactic.
That scare tactic, said Joel Barkin, spokesman for Representative Bernie Sanders (I-Vermont), is FDAs way of protecting the pharmaceutical industry, which, he said, is at war with American consumers who are seeking cheaper drug prices. And the pharmaceutical industry spends millions of dollars to lobby and support that war.
Sanders has been a long-time advocate for governmental control of drug prices. He has introduced legislation to legalize the reimportation of drug products.
Noble said her organization supports Sanders efforts and is actively involved in lobbying other members of Congress for legislation that would help U.S. consumers have access to lower-cost medications.
Until Congress or FDA can provide a solution to rising drug prices, Noble said, NA-PCA is dealing with the reality that people are buying drugs from Canada and Mexico.
That is why we need to have international standards, and that is why we were interested in starting our commission, she said. We are certainly not out there to break the law. But there needs to be some sort of guidelines.
FDAs Hubbard warned in his February letter that Internet and mail-order pharmacies caught violating FDCA could be held criminally liable. Also, those who aid and abet a criminal violation of the Act, or conspire to violate the Act, can also be found criminally liable.
State violations. Shipping prescription drugs to consumers in the United States may also violate state law, Hubbard noted, because many states require licensing and registration for pharmacies that ship drug products directly to consumers.
The National Association of Boards of Pharmacy (NABP) has been certifying Internet pharmacies in the United States through its Verified Internet Pharmacy Practice Sites (VIPPS) program since 1999.
The VIPPS seal of approval, said Carmen A. Catizone, NABP executive director, helps consumers identify online pharmacies that are appropriately licensed and have completed a criteria-based review and inspection.
NABP does not regulate online pharmaciesonly state boards of pharmacy, with some oversight from FDA, have the authority to regulate online pharmacies, Catizone noted.
His organization lists 13 online pharmacy Web sites as having active VIPPS certification. The program is voluntary.
VIPPS application fees range from $2000 to $5000, according to the programs most recent letter of agreement. The program charges a compliance review fee of $1500 per inspector per day, and applicants are also required to pay an average VIPPS inspection travel expense of $875 per inspector. Program participants must also pay an annual fee of $1000$4000 or, if it is an inspection year, $3375$6375.
One Internet pharmacy, PrescriptionOnline Inc. of Las Vegas, Nevada, reported in 2001 that the company spent $30,000$40,000 to complete its VIPPS certification process.
PrescriptionOnline was suspended from the program in August 2001.
Nevadas board of pharmacy closed down PrescriptionOnline in December 2002 after a two-year investigation and revoked its operating license. In a negotiated settlement, the regulatory board in January fined PrescriptionOnlines owner, Michael Cosenza, $200,000 for numerous violations.
Onsite inspections by Internet and mail-order pharmacy accreditation programs, NA-PCAs Noble said, will help weed out rogue companies.
Catizone said VIPPS also conducts onsite inspections using trained NABP staff members or, in some cases, by hiring state inspectors independently or contracting for their services through a states board of pharmacy.
Canadas National Association of Pharmacy Regulatory Authorities has contracted with NABP to use its program in their country.
VIPPS Canada certifies Internet pharmacies in Canada; however, pharmacies that ship drug products into the United States, in violation of U.S. law, are not eligible for VIPPS certification.
Crossing the border. FDAs Hubbard conceded in his February letter to Lombardi that the federal government has not often prosecuted consumers who bring drug products purchased in Canada into the United States.
Bus trips to Canada to buy lower-cost prescription drugs reportedly are fast becoming as much a popular trend for senior citizen groups as gambling excursions or cruise vacations.
But, Hubbard added, in an appropriate circumstance, FDA reserves the right to prosecute people bringing drugs purchased in Canada across the border into the United States.