首页 > 资讯 > 仿制药生产商与国际标准组织开战

出自识林

2014-08-30 WSJ

仿制药行业和ICH之间爆发了一场口水战。ICH因拒绝在其所有重要的负责监督药品安全、有效性、临床试验和生产实践决策的指导委员会上给仿制药生产商一席之地，惹怒了美国、欧洲、加拿大和其他国家贸易协会的伞形组织 — 国际仿制药联盟（International Generic Pharmaceutical Alliance，IGPA）。

ICH包括来自于不同国家的监管机构，如FDA，以及品牌药生产商。据美国仿制药协会监管科学高级副总裁和IGPA发言人David Gaugh称，目前仿制药企业已经加入了ICH会议，但仅是顾问作用。

在8月8日给ICH的信中，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。”

伞形组织指出，仿制药现在成为一个全球行业，事实上，美国处方的84%由仿制药构成。由于这些原因，IGPA认为制定国际标准的过程不仅应包括来自于仿制药企业的咨询顾问，仿制药企业还应在决策桌上得到充分认可的席位。

因此，信的结尾威胁：“如果IGPA无法作为指导委员会成员，那么我们将需要评估我们与ICH继续合作关系。”不过，Gaugh告诉我们，在ICH11月举行另一次会议之前，可能无法做出最终决定。

Gaugh告诉我们，“过去30年间，我们作为领域专家被邀请[到ICH讨论]参加标准制定过程。但是我们没有正式席位，而指导委员会有机会给我们这个席位。他们可以通过这样做创造平等地位。我们认为，如果我们对如何制造药品有见解，我们应当有决策地位。

欧洲仿制药协会代理总干事和监管事务负责人Beata Stepniewska给我们的信中指出“ICH的绝大多数指南成为直接适用于仿制药和生物类似物生产企业的监管要求和指南。”

她补充道，IGPA没有收到将仿制药企业排除在外的解释，但是在得知ICH 6月在Minneapolis的会议结果后发出这封信。我们要求ICH给出解释，但还没有收到回复。总之，我们将随时更新我们收到的回应。

校译： 识林-椒 2014-08-30

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.