Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

BIOTECH DRUG EXCLUSIVITY VIA WAXMAN/HATCH EXTENSION will be considered by Sen. Hatch (R-Utah) in the coming months. The co-sponsor of the Patent Term Restoration and Drug Price Competition Act is planning to meet with industry and government experts, possibly in December, to discuss ways of adjusting the law. Former staffer Doug Campbell, speaking on behalf of Sen. Hatch at an American Pharmaceutical Association symposium Sept. 16, said that "the arrival of the age of biotechnology has presented us with issues which we couldn't have forseen legislatively even four years ago." He pointed out that "FDA has to grapple with how to handle market exclusivity for drugs which incorporate minute molecular alterations, sometimes of questionable therapuetic effect, to pioneer biological drugs." Campbell is now with the public relations firm Fleishman Hillard. The Utah senator will solicit input from PMA, the Industrial Biotechnology Association and generic drug trade associations, as well as from patent experts, on if and how the law might be changed to address the problem, according to a Hatch staffer. IBA has been actively supporting biotechnology drug-related adjustments to Rep. Waxman's (D-Calif.) Generic Animal Drug and Patent Term Restoration Act (HR 4982), which was recently reported out of the House Judiciary Committee's subcommittee on Courts, Civil Liberties and the Administration of Justice. The association, for example, is supporting an amendment that exempts animal drug and biological products derived from biotechnology processes from the provisions of the bill. Sponsored by Rep. Moorehead (R-Calif.), the amendment also contains a provision that denies FDA approval for generic animal drugs made through biotechnology methods. A corresponding Senate version of the bill has been introduced by Sens. Kennedy (D-Mass.) and Hatch (R-Utah). In addition to outlining the impact of Waxman/Hatch, the speech notes other problems that have arisen since the law was passed in 1984. The speech points out that FDA is now "being required to reconcile the language of the law, which focuses on molecular composition, with the emerging recognition that different foldings of the same complex molecule may give rise to therapeutic differences." It adds that "the resolution of these issues will widely affect the course of development of the biotechnology industry." One of the senator's concerns with the uncertainty surrounding exclusivity for biotech drugs is the result that more funds are being devoted to litigation than research. "I am disturbed by the confusion concerning patents for different versions of the same chemical compound," Hatch said. He noted that the "result seems to be that the key research decisions are being made by patent lawyers rather than by scientists." Hatch suggested that one possible solution is "to give a period of exclusivity to pioneer biotech products unless a subsequent version shows a substantial improvement in benefit. This, of course, would require legislation. And I will be looking at this and other proposals in the coming months." Hatch indicated that legislative changes would not be considered for all the problems that have resulted from the law's implementation, including FDA's application of the law's bioequivalence standard. "Some difficulty arises . . . in applying the concept of bioequivalence for drugs not absorbed into the bloodstream," he pointed out. "Also," he continued, "there are questions about whether certain hormone products are fairly treated because of the difficulty of distinguishing blood levels due to therapy, from blood levels due to the body's natural production."

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts