Generic Industry Has the Wind at Its Back

NOVEMBER 01, 2007
Kathleen Jaeger, GPhA President and Chief Executive Officer

When it comes to continued growth in the generic pharmaceutical industry, "the wind is at our back," according to Doug Long, vice president of industry relations at IMS Health. Speaking at the Generic Pharmaceutical Association's (GPhA's) Annual Policy Conference, Long noted that the generic industry is growing at roughly 14%, a pace that is twice as fast as the world pharmaceutical market.

The reasons behind this substantial growth include the strong utilization of generics through the Medicare prescription drug benefit, an aging population with a growing reliance on medicines, and more than $50 billion in brand products that will be coming off patent during the next few years. Only the biotech sector is continuing to grow at a faster rate than generics, at 17.9%. With the increased growth in the biotech sector comes the hope of more cures, but also of increased costs for patients. A biotech drug used to treat colon cancer, for example, costs $100,000 a year, with some biologics costing many times more. With those high biotech prices in mind, it was no surprise that many conference speakers focused on the need for Congress to approve legislation giving the FDA the authority to approve generic versions of biopharmaceuticals, or biogenerics.

"Now is the time to pass legislation enabling the FDA to create an abbreviated regulatory pathway for safe, pure, and effective biogenerics," said Christopher Begley, president and chief executive officer of Hospira, Inc, which is actively investing in the biogeneric market. "When lifesaving drugs are not affordable—regardless of their safety and efficacy—they are irrelevant."

Congressman Frank Pallone (D,NJ), who chairs the House Energy and Commerce Subcommittee on Health, agreed on the need for Congress to take action on biogenerics. Although biogenerics legislation was not included as part of an FDA reform bill, Pallone asserted that the issue is still moving forward. Pallone pledged that the House of Representatives would continue to hold hearings on biogenerics and develop legislation in the coming months.

Biogenerics legislation is only one of many issues impacting the generic industry. Conference speakers also discussed citizen petitions and patentsystem reforms. Citizen petitions, which can deal with legal, regulatory, and scientific matters, are often filed with the FDA on the eve of a generic application's approval. The vast majority are dismissed without merit. Unfortunately, as FDA Deputy Commissioner Janet Woodcock, MD, pointed out, regardless of their merit, citizen petitions "are very labor-intensive," and their review can delay generics from coming to market in a timely manner. The delay could be days or even years, giving the brand company a longer monopoly and costing patients millions of dollars. Fortunately, legislation recently approved by Congress would address citizen-petition abuse by requiring petitions to be reviewed within a 6-month time period and would allow for the simultaneous consideration of the generic application and the petition.

10th Annual IGPA Conference
For a look at the international generic pharmaceutical industry, join us for the 10th Annual International Generic Pharmaceutical Alliance (IGPA) Conference from November 28 to December 1, 2007, in Miami Beach, Fla. Details are available online at

In addition, the House and Senate are considering patent-reform bills that would change the way generic companies undertake patent challenges. Some lawmakers want to make changes to inequitable conduct, which enables generic companies to challenge brand companies that use fraudulent statements and misconduct to garner patents from the Patent and Trademark Office (PTO). Depending on how the changes are made, it could result in the PTO mistakenly issuing patents or make it more difficult for generic companies to challenge questionable patents and bring an affordable medicine to market. The industry will be closely monitoring the legislation.

Whether it is patent reform, biogenerics legislation, or other health care matters, decisions made by lawmakers on Capitol Hill will affect the strength of the wind at the industry's back in the future. The industry will be working together to make sure that the wind is blowing in favor of increasing patient access to safe, effective, and affordable generics.