: FDA drug scrutiny rapped as uneven; Critics said the agency in the pocket of US drug makers

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FDA drug scrutiny rapped as uneven

>

> By Christopher Rowland, Globe Staff, 9/16/2003

>

> The Food and Drug Administration is serious about monitoring the safety of

> mail-order drug shipments in the United States -- if they come from

Canada.

>

> Last month, the agency conducted an unusual sting operation targeting the

> City of Springfield, which is importing lower-priced drugs from Canada for

> city workers to reduce the spiraling cost of drugs bought in the United

> States. In an elaborate undercover operation, the FDA received at room

> temperature a single order of insulin that should have been chilled. The

> agency publicized the sting nationally to illustrate what it described as

> the dangers of ordering drugs by Internet from Canada.

>

> But the FDA takes a hands-off approach to enforcing the much greater

volume

> of prescription shipments from US Internet mail-order pharmacies, where

> increasing numbers of Americans get their drugs. In fact, FDA officials

> said they can't recall ever conducting a domestic sting operation

targeting

> the quality of insulin or other drug shipments.

>

> Critics said the agency is in the pocket of US drug makers, which have

> vigorously tried to shut down Canadian imports.

>

> " I'm very concerned that they are selectively enforcing here, " said

> Springfield Mayor Michael Albano, who is heading to Washington for

meetings

> today with FDA officials to make his case. " They're doing the

> pharmaceutical companies' bidding to try and stop the momentum. "

>

> Though rising, Canadian drug imports totaled just $700 million last year.

> In comparison, Americans buy that amount of drugs every 10 days from

> domestic mail-order prescription businesses, and the level is growing

fast.

>

> Meanwhile, there are concerns that the lack of FDA oversight of US

> shipments is a problem. According to a study using dummy packages with

> temperature sensors sent to 32 states, one in four mail-order prescription

> deliveries in the US is likely to be exposed to " excessive heat " while en

> route to the consumer. In some cases, especially with biologic drugs,

> excessive heat can diminish the drugs' effectiveness.

>

> The study was conducted by US Pharmacopeia, a Rockville, Md., nonprofit

> group that sets national standards for pharmacies. The group has

> encountered industry resistance to spending on new technology to ensure

> safer deliveries.

>

> " I have never, ever had insulin arrive cool in 13 years of buying it "

> through domestic mail order, said diabetes patient Tom Boyer of San

> Francisco. He throws the lukewarm cold packs that arrive with his 90-day

> insulin supplies into the freezer. When they get cold again, he uses them

> to soothe a sore knee.

>

> Independent US Representative Bernard Sanders of Vermont, who advocates

> legislation to allow the importation of low-cost Canadian drugs, said the

> Springfield sting and lack of US enforcement are evidence that the FDA is

> helping drug companies protect higher drug prices paid by American

consumers.

>

> " The FDA is working for the pharmaceutical industry, which contributes

huge

> amounts of money to the Republican Party and the president, " Sanders said.

>

> The FDA declined to respond specifically to charges that the agency favors

> industry.

>

> " Our policy is based on promoting the safety of the American people, " said

> Brad Stone, an agency spokesman in Washington. William Hubbard, the FDA's

> associate commissioner for policy and planning, said the Springfield sting

> was necessary because there are no other mechanisms to hold Canadian

> companies accountable.

>

> Hubbard said the FDA " absolutely " has the jurisdiction to regulate the

> safety of domestic mail-order shipments. But he said enforcement at the

> state level ensures that consumers are protected.

>

> " No American pharmacist is going to give you hot insulin, " he said. " He's

> going to be subject to licensure, subject to inspection, subject to a

> complaint from a patient. His business is going to be at risk. This guy in

> Canada has nothing at risk. "

>

> The Springfield municipal program has been a focus of the FDA since Albano

> unveiled it in July. Importing prescription drugs from Canada is illegal,

> yet the FDA has declined to enforce the prohibition for individual

> consumers. The purchases have increased over the last four years as

> Americans desperate to reduce their medicine costs have found discounts as

> low as 50 to 80 percent on brand-name drugs north of the border, a result

> of Canadian government price controls. The US House has passed a bill that

> would make Canadian sales in the United States legal. The proposal is

hotly

> opposed by the FDA and industry, which say American consumers could be

> exposed to counterfeit, expired, or improperly stored medicine from

Canada.

>

> It was against this backdrop that the FDA, using an assumed name and

> address, took action last month against Springfield's supplier of Canadian

> drugs, CanaRx Services Inc., based in Windsor, Ontario. The FDA said the

> sting resulted in a room-temperature batch of insulin that should have

been

> delivered refrigerated. Hubbard said the package was not insulated but

> declined to release other details.

>

> In the United States, some diabetics say insulin ordered from domestic

> mail-order companies often shows up at their doorstep at room temperature.

>

> Concord author Philip Luber said he tried mail-order insulin for his

> daughter in 1999. The insulin that arrived via Federal Express, he said,

> was not refrigerated and arrived lukewarm. After his daughter began

> injecting the new batch, her glucose levels did not fall sufficiently --

> evidence, he believes, that the insulin had been degraded by extreme heat

> during shipment. Luber persuaded his insurance company to allow him to

> purchase the insulin at a local drugstore instead. " The packages they were

> using were called insulated packages. It had layers of something in it,

> bubble-wrap or other insulation, " he said. " But if you stick any kind of

> package in a hot truck for a couple of days in the middle of August, it

> doesn't matter. "

>

> For at least the past five years, US drug companies, wholesalers, and

> mail-order pharmacies have joined forces to oppose a set of proposed

> national prescription-shipping standards that would include the use of

> temperature sensors in packaging to tell consumers if their mail-order

> prescriptions had been exposed to extreme heat or cold. Without such

> sensors, proponents say, patients have no way of knowing if the drugs

> arriving on their doorstep were baked in a truck in the Arizona desert or

> frozen solid in the belly of a cargo plane.

>

> " The concern has always been that when a mail-order pharmacy ships, it's

> being sent to the consumer under uncontrolled conditions, " said Eric C.

> Sheinin, vice president for standards development at US Pharmacopeia, the

> standard-setting group.

>

> US mail-order companies are generally regulated by individual state boards

> of pharmacy following US Pharmacopeia guidelines.

>

> The FDA's Hubbard said the agency's rules establish US Pharmacopeia as the

> standard-setting entity for the operation of pharmacies, including

> national-scale pharmacies that ship across state lines. But US

Pharmacopeia

> said it has no shipping standards, which has been a source of concern

among

> some US Pharmacopeia officials. A 1997 study by the organization, in which

> test packages were shipped to 32 states, demonstrated that 26.1 percent of

> mail-order drugs were exposed to " excessive heat " of 104 degrees or more,

> well above the tolerance for insulin, for example. A 1995 study found that

> temperatures in St. Louis mailboxes reached 136 degrees.

>

> Manufacturing guidelines for insulin say it should be stored in a

> refrigerator, although it can be kept safely at room temperature for up to

> 28 days. It loses effectiveness when it is exposed to greater than body

> temperature. The problem for mail-order consumers is that there is no way

> to tell by looking at the product if it has been heated beyond tolerable

> levels. Freezing insulin renders it almost completely ineffective, but

> there are telltale signs of freezing, such as a cloudy appearance.

>

> The National Community Pharmacists Association has called on the federal

> government for greater regulation of Internet mail-order pharmacies, to no

> avail, said John M. Rector, the association's general counsel.

>

> US Pharmacopeia has repeatedly proposed national guidelines to safeguard

> drugs in shipment, including the insertion of temperature sensors into

> packages of sensitive prescriptions like insulin and synthetic hormones.

> Those proposals have been defeated by " push-back from industry, " which

> holds seats on the US Pharmacopeia governing bodies, Sheinin said. The

> organization's leadership plans to unveil a fresh set of proposals within

> two weeks.

>

> The FDA's director of pharmacy affairs, Tom J. McGinnis, said the FDA

would

> enforce whatever standard US Pharmacopeia adopts. Thus far, he said, the

> agency has not seen the need for independent action.

>

> " FDA looked at this issue in the past, at least 10 years ago, when

> mail-order pharmacies started getting big, " he said, " and we didn't see

any

> degradation of strength, quality, and purity at that time. "

>

> The Pharmaceutical Care Management Association, which represents

mail-order

> pharmacies, and the largest mail-order pharmacy, Medco Health Solutions

> Inc., declined to comment on US Pharmacopeia's proposals for temperature

> sensors. In the past, according to copies of industry newsletters,

> mail-order pharmacies, wholesalers, and drug manufacturers have said that

> requiring sensors would present an unfair regulatory burden, raise

handling

> costs, and increase the likelihood that consumers would return drugs to

> mail-order retailers. " Mail-order pharmacy sources are already

> appropriately regulated by state boards of pharmacy, " said Tim Brogan, a

> spokesman for the Pharmaceutical Care Management Association.

>

> Medco Health Solutions, a subsidiary of drug maker Merck & Co., said

> mail-order pharmacists take great pains to make sure drugs arrive in good

> shape. Medco spokeswoman Ann Smith cited several measures including

> overnight or expedited shipping, iced or gel-packed insulated containers,

> and follow-up calls to an insured patient to see if the package arrived on

> time.

>

> " We believe that our protocols are extremely rigorous, " she said.

>

> Christopher Rowland can be reached at crowland.

> fe

>

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