By Lisa Seachrist

Washington Editor

WASHINGTON - With the cost of prescription drugs becoming a hot campaign issue, several members of the House have proposed legislation that would permit the reimportation of FDA-approved prescription drugs for personal use from countries with lower prices.

The measures have taken the form of stand-alone bills and amendments to appropriations legislation. Not all are specific in what they would permit.

"These bills come from a combination of Republicans, Democrats and Socialists," said Chuck Ludlam, vice president for government relations at the Biotechnology Industry Organization (BIO). "It gives you an ominous indication of the politics of drug prices in the Congress at the moment."

The House passed a bill sponsored by Gil Gutknecht (R-Minn.) that would alter the way in which FDA sends a warning notice to people who illegally import prescription drugs. The real impact of the bill, H.R. 3240, is in dispute. The bill could be a way of stripping away the FDA's ability to issue warning letters. Or it could simply add another hurdle to issuing a warning letter.

BIO is concerned the bill could be used in conference as a way to pass a price control measure. Last month the House adopted an amendment proposed by Bernie Sanders (I-Vt.) to the Labor and Health and Human Services appropriations bill that would allow biopharmaceutical companies to license technology developed at the National Institutes of Health only if they agree to sell any future products at a "reasonable price." Such a clause existed prior to 1995, but then-NIH Director Harold Varmus rescinded that policy in order to encourage industry to develop NIH technologies.

Reps. Joseph Crowley (D-N.Y.) and Tom Coburn (R-Okla.) introduced amendments to the Agriculture Department appropriations legislation. Crowley's amendment would forbid the enforcement of FDA authority on the reimportation of FDA-approved prescription drugs if they were for personal use. Coburn's language states the FDA may not use any appropriated funds to interfere with the importation into the U.S. of drugs that have been approved for use within the United States and were manufactured in an FDA-approved facility in the U.S., Canada or Mexico.

"These amendments ignore legitimate consumer safety concerns that have been stated by former Commissioner David Kessler and echoed by FDA Commissioner Jane Henney and many other protectors of consumer safety," Ludlam said. "Manufacturers in the U.S. are heavily regulated. If [reimportation] becomes law, a whole new market of counterfeit or contaminated drugs could develop."

NAS Report Calls For Helping Developing Countries

Last Monday the National Academy of Sciences, in conjunction with other international scientific organizations, issued a report calling for the application of biotechnology to agriculture in developing nations in an effort to fight hunger, improve the environment and stabilize economies.

The report, titled "Transgenic Plants and World Agriculture," calls for developed nations to increase their assistance to developing nations. In addition, the report calls for the private sector to collaborate with government in order to get biotech advances to farmers in developing nations.

"We agree with the report's conclusion that much more needs to be done," said Michael Phillips, executive director of the food and agriculture section at BIO. "But you can't look to the private sector alone to do all the work. We need to have much more collaboration between the public sector and the private sector, with the public sector taking the lead on this."

Phillips noted biotechnology companies have in fact donated a fair amount of technology to developing countries. He pointed out biotech companies working with the Rockefeller Foundation donated Golden Rice - rice capable of producing vitamin A and iron - to fight blindness and anemia in adults. In addition, he pointed to the work on the rice genome in which private and public researchers are working to create an important reference tool.

"The private sector really has a pretty good record," Phillips said. "It's almost scandalous the way the developed countries have pulled foreign aid away from the developing countries. We have to get leaders and government to understand the importance of foreign aid."

Penn Receives Second Warning Letter

The University of Pennsylvania's Institute for Human Gene Therapy received a second warning letter July 3 from the FDA concerning three animal experiments conducted in conjunction with a gene therapy experiment that resulted in the death of an 18-year-old volunteer.

The sharply worded letter concluded Director James Wilson and the IHGT failed to fulfill the obligations of a sponsor of nonclinical studies with investigational vectors and violated Good Laboratory Practices (GLP) regulations governing the proper conduct of nonclinical studies involving investigational vectors. The letter maintains Wilson, as study director, failed to fulfill requirements to document and support protocol deviations in a timely manner.

Wilson had told the FDA the problems were limited in scope. In its warning letter, FDA didn't see the problems as limited. The letter states, "We do not agree that these instances were isolated because such deviations were noted in each of the three studies reviewed during inspection. The inadequate level of documentation for these three studies, which occurred during the period in which IHGT states that it was implementing improvements, casts doubts about the reliability and completeness of the remaining study records."

Ken Wildes, director of communications for the university, told BioWorld Today, "We believe many of the issues were being addressed at the time of the audit and we believe IHGT has made substantial progress. But we continue to work very hard to respond to these concerns."

The agency highlighted problems with managing and storing data, assuring the quality of the vector preparations used and failing to prepare written standard operating procedures. In addition, the agency pointed out Wilson and IHGT never addressed whether acknowledged protocol deviations affected the quality or reliability of the animal studies in question.

IHGT and Wilson had 15 business days to respond to the agency's letter. After that the agency will determine whether any additional judicial or administrative activities are warranted.

This is the second warning letter Wilson and IHGT have received following the death of 18-year-old Jesse Gelsinger, a participant in a Phase I gene therapy study for patients with ornithine transcarbamylase deficiency (OTCD). He died days after receiving a hepatic infusion of an altered adenoviral vector.

Gelsinger's death brought the Penn program, and gene therapy in general, under intense scrutiny, resulting in a clinical hold for all gene therapy research at IHGT, calls to strengthen the role for the Recombinant Advisory Commission and a number of Congressional hearings. (See BioWorld Today, Feb.22, 2000, p. 1; and March 7, 2000, p. 1.)

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