Flu vaccine shortage highlights need to accelerate the approval of affordable generic biopharmaceuticals and vaccines

Oct 8 2004

Following the announcement that the nation is facing a flu vaccine shortage this year, the Generic Pharmaceutical Association (GPhA) renewed its call for the Food and Drug Administration (FDA) and Congress to move forward to accelerate the approval of affordable generic biopharmaceuticals and vaccines.

"The shortage of the flu vaccine is another case in point as to why the federal government needs to accelerate the legal pathway for generic biopharmaceuticals and vaccines," said GPhA President and CEO Kathleen Jaeger.

"Generic companies stand ready to prevent this crisis from recurring," continued Jaeger, who noted that she would make the industry's position known to the House Government Reform and Oversight Committee, which will be holding a hearing on the flu vaccine shortage on Friday. "We're hopeful that the federal government will soon realize that it has yet to tap into the breadth, depth and capabilities of the generic pharmaceutical sector. Among our member companies, Barr, for example, is manufacturing a vaccine for the Department of Defense, while TEVA is currently manufacturing a therapeutic protein (copaxone).

"Generic alternatives would help stabilize the drug supply for critically needed drug products such as the flu vaccine in a market with limited players.

A competitive market spurs both innovation and price competition," she said. "Given escalating pharmaceutical expenditures and the broader health care crisis, the time is now for the FDA and Congress to commence competition for expensive biopharmaceutical medicines so that consumers can have timely access to these lifesaving products."

Biogenerics are generally large protein molecules derived from living cells, such as antibiotics, insulin and human growth hormone. While the United States is debating the manufacture of generic biopharmaceuticals, citizens of other nations are already enjoying access to more affordable generic biopharmaceutical products.

Jaeger pointed out that generic companies have highly sophisticated research and development capabilities and are ready to enter the U.S. biopharmaceutical market. Generic pharmaceutical companies also adhere to the same scientifically sound principles and standards as those relied upon by the brand sector.