首页 > 资讯 > GPhA就标签拟议规定陈词

出自识林

2014-03-11 Lachman CONSULTANTS

仿制药生产商协会（GPhA）就标签拟议规定陈词 — 听证会暂推迟，民主党议员施以阻力

FDA拟定的补充申请规则—获批药品与生物制品标签变更， 成为今年仿制药生产商协会（GPhA）年度会议各方热议的焦点，很明显所有参会者都在思考这一问题。仿制药生产商协会（GPhA）总裁兼首席执行官Ralph G. Neas，原定于3月3日在众议院能源和商务委员会健康分委会的听证会上，阐明如果按照目前所陈述的，这一关乎有关仿制药行业的拟议规定将给仿制药企业、患者以及医疗工作者，带来何种不利影响。遗憾的是，该听证会受天气影响而推迟。

该规定将允许任一仿制药申请者单方面修改其标签，纳入新的警告或安全性信息。虽然表面上看这一提案论及患者安全，但事实上，这一规定撼动了《Hatch-Waxman法案》30多年来所要求的标签一致性以及FDA自己的现行法规的核心。《Hatch-Waxman法案》通过提供特定的激励，诸如专利期恢复、专利清单规定以及对于新药有不同类型的市场专营期，使得品牌药厂家的创新与消费者获取高质量仿制药达成微妙的平衡。GPhA的证词间接提到这一拟议规定将带来的一些问题：

• 增加开支 — 一项为GPhA开展的有关拟议规定所带来经济影响的研究，估计该规定将给美国公众增加约40亿美元的开支。
• 因同一产品具有多种版本的警告，使用时将给医生、护士、药师以及患者带来混乱，因此造成产品并不等效于另外产品的假象。
• 由于仿制药生产商或为规避潜在的诉讼而退出市场，该规定事实上将减少患者获得特定药品，带来药品短缺，抬高药价。
• 法律要求标签一致性，然而此规定可能与有关条例的平稳运作直接冲突。
• 仿制药生产商仅有一小部分源自其产品的药物警戒活动的安全信息。另一方面，FDA掌握有一种特定市售产品所报告的所有不良药品事件，因此FDA更适于评估相关数据，决定一项标签变更是否必要。
• 如果要求仿制药生产商若基于不完备的信息单方面大量变更标签，仿制药生产商可能会为避免诉讼而夸大风险、纳入未经证实的警告，并因此扰乱市场秩序。
• 品牌药与仿制药企业将面临大量侵权诉讼支出。
• 这些诉讼支出将扩展至药师以及其它医疗工作者，带来整体价格提高。

正如Ralph Neas在书面材料中所声明的，“仿制药企业将继续与国会、FDA以及其它利益攸关方一道，确保对标签规定的任何变更保护患者安全、符合联邦法律，而不是阻碍患者获得仿制药”。目标是保证患者安全，通过有序、合理的渠道开展标签变更，而不是因为执行目前成文的拟议规定而破坏现行的一致性标准、引发市场的大规模混乱或引起仿制药价格大幅提高。在过去十年间，Hatch-Waxman法案已为政府与消费者节省超过1.3万亿美元，我们不应采取有悖于这一趋势的措施。

Insidehealthpolicy.com网站在今年3月初发表了一篇题为《FDA仿制药标签规定“毫无根据”，民主党请三思药品开支》的文章。民主党人应该走出国会山，聆听来自药企、药房以及医疗工作者的意见，而不是仅仅与原告的律师交流讨论。我们从其它地方得到的消息是，诉讼开支将显著增加，标签变更开支也将提高，上述两项以及责任险保费与律师付费的增加的负担也会落到药店头上，以而发给患者的处方信息表也会一直在变。我作为一位工作了42年的药剂师，在FDA与制药行业供职超过30年。民主党（至少那些认为近期制定的标签变更规定是好事情的人）的想法即将变为现实！我并非通过选举获得现有位置，因此也不必代表任何人。我的出发点仅是为了美国人民以及我的客户竭尽所能。可以有很多途径保证新信息尽快纳入标签，同时不会带来拟议规定可能制造的混乱。对于受害于任何出现新的此前未确证安全性问题的药品的患者，如果民主党人的确关注其补偿，他们应确保标签准确，警告基于科学，并在作出变更之前得到了FDA的认同。此外，如果他们的动机纯而又纯，确实想将赔偿送至患者而不是代表患者的律师手中，那么，他们可探讨类似于疫苗赔偿计划的计划。

Lachman CONSULTANTS - Bob Pollock先生 2014-03-06
校译：识林-Kapok 2014-03-10

GPhA Testimony on FDA's Proposed Label Rule – Hearing Delayed but Democrats Balk
Written by Bob Pollock • March 06, 2014

The FDA's Proposed Rule Supplemental Applications: Proposed Labeling Changes for Approved Drugs and Biological Products occupied the podium time of many speakers at this year's Generic Pharmaceutical Association's (GPhA) Annual Meeting and was clearly on the minds of all attendees. Ralph G. Neas, CEO and President of GPhA, was to testify before the House Energy and Commerce Subcommittee on Health on Monday March 3 to explain just what a detrimental impact on the generic industry the Proposed Rule, as currently written, will have on the generic drug industry, patients, and healthcare providers. Unfortunately, the weather postponed the hearing.

The Rule would allow any Generic applicant to make a unilateral change to its label to include new warnings and or safety information. While on its face the proposal appears to speak to patient safety, in reality, the Rule strikes at the heart of the 30+ years of label sameness required by the Hatch-Waxman Act and FDA’s own current regulations. The Hatch-Waxman Act struck a delicate balance between innovation for the brand industry and access to high quality generic products for consumers by providing special incentives, such as patent term restoration, patent listing provisions, and periods of various types of market exclusivity for NDA product. GPhA‘s testimony alludes to some of the problems this Proposed Rule will create.

• Increased costs – as outlined in a study performed for GPhA regarding the economic impact of the Proposed Rule (here) which estimated that the Rule will cost the American public some $4 billion dollars.
• Confusion in the marketplace among physicians, nurses, pharmacists and patients by having multiple versions of warnings for the same product, thus creating the false impression that one product may not be equivalent to another.
• The Rule would actually decrease patient access to certain drugs, as generic manufacturers may flee markets in fear of potential litigation, creating drug shortages and increased drug prices.
• The law demands label sameness, yet the regulation appears to be in direct conflict with the plain working of the statute.
• Generic manufactures only have a slice of the information on safety through their pharmacovigilance activities on their product. On the other hand, the FDA has access to all adverse drug events reported by all of the marketers of a specific product, and thus, FDA is better positioned to evaluate this data and decide whether a label change is warranted.
• Requiring generic makers to make unilateral label changes based on incomplete information will lead to a flood of unnecessary label changes, potentially exaggerating risk and inclusion of unsubstantiated warnings in an effort to avoid liability, thus creating confusion in the market place.
• Brand and generic firms will be exposed to substantial tort liability costs.
• These liability costs will also extend to pharmacists and other healthcare providers leading to an overall increase in pricing.

As Ralph Neas written testimony stated “The generic pharmaceutical industry will continue to work with the Congress, FDA, and other stakeholders to make sure that any changes to labeling rules and regulations protect patient safety, align with federal laws, and do not hinder patient access to more affordable generic medicines.” The goal of all is to assure patient safety through an orderly and reasoned approach to label changes that will not disrupt the current sameness standard so as not to create wholesale confusion in the marketplace or to cause significant cost increases in generic drug prices that will result from implementing the Proposed Rule as currently written. After all Hatch-Waxman has saved the government and consumers over $1.3 trillion over the last decade, let's not take a step to reverse that trend.

An article was published today in Insidehealthpolicy.com today entitled “Democrats: Concerns About Drug Costs Under FDA Generic Labeling Rule 'Unfounded'”. Well, those Democrats should get off Capitol Hill and get out to the drug companies, the pharmacies, talk to healthcare providers instead of speaking or listening only to the Plaintiff's bar. The message we get from the rest of the world is that liability costs will increase dramatically, label change costs will soar, pharmacies too will incur both of these increases in cost as they have to deal with rising liability premiums and lawyers’ fees, as well as a constant change in the patient information sheets handed out with each prescription. I have been a pharmacist for 42 years and have spent 30 years in FDA and the drug industry. Come on Democrats (at least the ones that think this label change regulation as currently written is a good thing) - get real! I did not get elected to any of the positions I held and thus I was not beholden to anyone I represented, I just did the best job I could for the American people and my clients. There are numerous ways to assure the new information gets into labeling as soon as possible without creating the confusion the Proposed Rule will create. And if the Democrats are really concerned about compensating patients that are injured by a drug – any drug because of new previously unidentified safety issues, they should be sure the labels are accurate, that the warnings are scientifically based and that the FDA agrees with the changes before they are made. Also, they should investigate a program like the Vaccine Compensation Program if their interest is genuine as this will place the compensation in the hands of the patient and not attorneys that represent them.

For a complete copy of the GPhA testimony please visit the GPhA web site at http://www.gphaonline.org/issues/generic-drug-labeling