Generic Drug Makers Tussle With International Standards Group
By ED SILVERMAN
A nasty spat has broken out between the generic pharmaceutical industry and an international organization that develops widely accepted standards for developing prescription drugs.
The International Generic Pharmaceutical Alliance, an umbrella group for trade associations from the U.S., Europe, Canada and other countries, is miffed that the International Conference on Harmonization has refused to give generic drug makers a position on the all-important steering committee that oversees decisions on drug safety, efficacy, clinical trials and manufacturing practices.
The ICH is comprised of regulatory agencies, such as the FDA, from various countries, and brand-name drug makers. To date, the generic pharmaceutical industry has participated in ICH meetings, but only in an advisory role, according to David Gaugh, a senior vice president for regulatory sciences at the U.S. Generic Pharmaceutical Association and an IGPA spokesman for this particular issue.
In an Aug. 8 letter to ICH, the umbrella group wrote that a decision last June to rebuff generic drug makers means the “generic industry will remain completely barred from the formal ICH decision-making process, even though the vast majority of ICH guidelines become regulatory requirements and guidances that are directly applicable to generic pharmaceutical manufacturers.”
To bolster its case, the umbrella group notes that generic drugs now constitute a global industry and, in fact, constitute 84% of the prescriptions written in the U.S. For these reasons, the IGPA argues that the process for setting international standards should include not only advisory input from generic drug makers, but the generic industry deserves a fully recognized seat at the decision-making table.
And so, the letter ends with some sabre rattling: “If IGPA is not included as a steering committee member, then we will be required to evaluate our continued relationship with and involvement in ICH.” However, Gaugh tells us that a final decision will most likely not be made until the ICH holds another meeting in November.
“Over the past 30 years, we’ve been invited [to ICH deliberations] as subject matter experts in the standards-setting process,” Gaugh tells us. “But we’ve not had an official position and the steering committee has an opportunity to grant this. By doing so, they would create parity. We think if we have an opinion how drugs are made, we should have a decision-making role.”
And Beata Stepniewska, the deputy director general and head of regulatory affairs at the European Generic Medicines Association, writes us to point out that “the vast majority of ICH guidelines become regulatory requirements and guidances that are directly applicable to generic and biosimilar pharmaceutical manufacturers.”
She adds that the IPGA has not received an explanation for excluding the generic industry, but sent its letter after learning the results of the ICH meeting in June, which was held in Minneapolis. We asked the ICH for comment, but have not received a reply. In any event, we will update you with any response that we do receive.
中，伞形组织写道，6月份生硬回绝仿制药生产商的决定意味着“仿制药行业将继续完全被正式的ICH决策制定过程排除在外，尽管ICH的绝大多数指南成为直接适用于仿制药生产企业的监管要求和指南。”