By Lisa Seachrist

Washington Editor

WASHINGTON - With FDA reform law passed and the agency busily working to implement those statutory changes, the Pharmaceutical Research and Manufacturers of America (PhRMA) is setting its priorities for the 106th Congress.

Major priorities for the industry representatives are to assure Congress that the medicines coming to market in 1999 are as safe as any that have preceded them and to prevent any attempts to set drug price controls.

"Among the themes that you are going to hear from us in 1999 include the importance of basic biomedical research, a transparent and efficient regulatory process both at the FDA and around the world, and a global business environment that allows companies to capitalize on their investments," said Alan Holmer, PhRMA president. "And, finally, and I think most importantly, companies need to be able to sell their products in a free market environment that recognizes the extraordinary risks that they face getting their products to market."

Holmer highlighted the 30 new drugs and nine new biologic products that FDA approved in 1998. While noting that medicines were going to cost more than $400 billion a year, he also pointed out that the companies would be spending $24 billion on research and development in 1999 to bring even more medicines to market. One of the most serious threats to innovation, in Holmer's eyes, is price controls.

Proposed Medicare Drug Price Controls Targeted

"The $24 billion in R&D costs for 1999 is a 14 percent increase over 1997," Holmer said. "In the U.S., the increase is going to be approximately 17 percent. Outside the U.S., that increase is 2.1 percent. What is going on here is that the U.S. has a legal and regulatory environment that nurtures innovation."

Holmer said that other countries with price controls have much less innovation in medicine. Even so, U.S. legislators have proposed price controls for drugs and biologics - a move PhRMA intends to fight.

"Our most immediate challenge in 1999 is the so-called Allen or Turner proposals," Holmer said. In the 105th Congress, Rep. Thomas Allen (D-Maine) and Rep. Jim Turner (D-Texas) introduced legislation that would require pharmacies that that are selling medicines to Medicare beneficiaries to purchase those medicines at federal schedule prices.

Holmer pointed out there was no provision in either of the proposals that the pharmacist must pass those savings on to their Medicare customers. While that loophole is likely to be tied up in any measures that are proposed in the 106th Congress, Holmer maintains that such a measure would require that pharmacists establish two separate drug inventories and leave the pharmacists open to abuse and fraud investigations by the Department of Health and Human Services.

"This is bad medicine for seniors and bad medicine for all patients," Holmer said. "Throughout all of this we need to focus on the value of pharmaceuticals," he said. "In many instances overall drug expenditures may go up, but overall healthcare costs go down with new medicines."

In recent months, several consumer organizations have questioned whether the FDA has lowered its standards as a response to statutory deadlines. Holmer maintains such allegations simply are false.

"It's easy to express concern and take a small number of individual cases and say that there is a problem with FDA," Holmer said. "The system is working. Patients believe the system is working and the companies that have had problems with their drugs have moved quickly and voluntarily to move them off the market when needed."

Holmer said that FDA continues to be the gold standard of the world when it comes to safety. He also said he reamins confident that newly appointed FDA Commissioner Jane Henney will keep the agency science-based.

In addition, Holmer noted that FDA staffers repeatedly have been stressing the problems of adequate funding at the agency. Holmer said that PhRMA considers funding a very important issue and the organization would continue to be helpful to the agency and Henney in their efforts to garner adequate appropriations for the agency.

Calling intellectual property the "lifeblood" of the pharmaceutical industry, Holmer said that PhRMA will pursue a day-by-day patent restoration for days lost in the regulatory process. However, the organization has yet to determine exactly the tack it will take with this Congress.

In addition to pricing and patent issues, medical privacy legislation is likely to be on the agenda early on for the 106th Congress since it has an August 1999 deadline for developing such protections under the Health Insurance Portability and Accountability Act. In the absence of such legislation, Health and Human Services Secretary Donna Shalala will promulgate medical privacy regulations.

Holmer said that whatever happens, PhRMA will work to ensure that the bill doesn't put up barriers to access to anonymous databases for biomedical and pharmaceutical researchers. n

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