首页 > 资讯 > FDA今年将对上市销售的未获批产品采取执法行动

出自识林

2014-01-12 Lachman CONSULTANTS

2014年：FDA开始对上市销售的未获批药品采取强有力的执法行动

2013年．几乎没有见到对上市销售的未获批药品采取执法行动，FDA将于2014年1月10日在“联邦公报”（FR）发布两份针对若干药品的强制措施的通告。

FDA将对某些未获批就上市销售硫酸可待因、磷酸可待因和二氢可待因的药品采取行动，这些药品含有未获批ANDA（Abbreviated New Drug Application，简化新药申请）或NDA（New Drug Application，新药申请）或完全符合适用的非处方药（OTC）专论（用于6岁及以上儿童的可待因止咳糖浆）的。预发布的FR通告请见此处。FDA指出，对所有不在完全符合《联邦食品、药品、化妆品法案（FD&CA，Federal Food, Drug and Cosmetic Act）》第510节的药品清单中的药品，执法措施将于2014年1月10日FR通告发布当日同时生效。对于符合该法案条文的药品，FDA将行使如下的执法自由裁量权：自FR通告发布之日起45天后不得再生产、90天后不得再配送产品。FDA解释，设置执法自由裁量权这一窗口，是给企业一个机会，清空其库存，同时也提供给患者一个机会，有序地将其用药转向取而代之的已获批药品。

在一份单独的FR通告（请见此处）中，FDA公布了多个尚未付诸实施的DESI（药效研究与实施，drug efficiency study and implementation）听证会要求的决议，这些要求将导致对受制于这些要求的已上市药品或可能上市的类似及相关药品采取执法行动。该FR通告覆盖的药品品类包括：

• 未被ANDA或NDA覆盖、或尚待批准和不以适用的DESI审评证明有效的适应症（结肠过敏、结肠痉挛、粘液性结肠炎）上市销售的盐酸双环胺药品。
• 某些含有黄嘌呤衍生物及苯巴比妥（处方药或在OTC专论下的）或盐酸羟嗪的药品
• 含100mg氯噻嗪的药品（该规格存在安全性问题，但25mg及50mg的较低规格不存在）
• 某些固定剂量复方抗生素及磺胺类药品（如Urobiotic — —种土霉素、磺胺甲二唑和非那吡啶的复方）

尽管上述许多药品不再上市销售，FDA仍指出“这些名录中认定的所有药品，或与名录中药品相同、相关、或类似的药品（简称为IRS产品, identical, related, or similar (IRS) product），不属于获批的NDA、ANDA（不同于符合适用OTC专论的非处方药品（OTC））的药品，自本通告生效之日起，以州际贸易的形式发货均为非法。”

随着2014年的这一开端，问题在于，在经历了处理未获批销售药品极度缓慢的一年之后，今年会成为具有持续性、确实采取执法行动和努力的一年，还是这一措施仅仅是针对2014年的权宜之计呢？
Lachman CONSULTANTS - Bob Pollock先生 2014-01-09
校译：识林-Kapok 2014-01-12

2014 Starts Out with a Strong Unapproved Drug Enforcement Action
Written by Bob Pollock • January 09, 2014

With little activity seen in 2013 in the enforcement arena for marketed unapproved drug products, FDA will publish two Federal Register (FR) notices on January 10, 2014 addressing enforcement action for a number of products.

FDA will move against certain unapproved marketed codeine sulfate, codeine phosphate and dihydrocodeine containing products marketed without approved ANDAs or NDA or in full compliance with an appropriate OTC monograph (codeine cough syrup for children 6 years of age and older). The prepublication of the FR notice can be found here. FDA notes that enforcement dates will concur with the publication of the notice in the FR on January 10, 2014 for any drug products that are not listed in full compliance under Section 510 of the Federal Food, Drug and Cosmetic Act. For those products that are compliant with the listing provisions of the Act, FDA will exercise enforcement discretion as follows: Firms may not manufacture product for more than 45 days from date of publication of the FR notice and may not distribute product for more than 90 days after the FR publication. FDA explains that this window of enforcement discretion is designed to give firms a chance to deplete their inventory and give patients a chance for orderly transfer of their medication to an alternate approved product.

In a separate FR notice (here), FDA announced the resolution of a number of outstanding DESI hearing requests that will result in enforcement action against marketed drug products that are subject to those requests or for similar and related products that may be marketed. The categories of products that are covered by this FR notice include:

• Dicyclomine hydrochloride products not covered by an ANDA or NDA or are subject to an approved application and not marketed for one of the indications found effective under the applicable DESI review (irritable colon, spastic colon, and mucous colitis).
• Certain products containing a xanthine derivative and either phenobarbital (prescription or under an OTC monograph) or hydroxyzine hydrochloride.
• Chlorthalidone products containing 100mg (safety issues for this strength, but not for the lower 25mg and 50mg products)
• Certain fixed combination antibiotics and sulfonamides (e.g., Urobiotic-a combination of oxytetracycline, sulfamethizole and phenazopyridine)

While many of the above products are no longer being marketed, FDA notes that “[S]hipment in interstate commerce of any of the products identified in these dockets, or any identical, related, or similar (IRS) product to the products in these dockets, that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) (other than an over-the-counter (OTC) product that complies with an applicable OTC monograph) is unlawful as of the effective date of this notice.”

With this start to 2014, the question becomes will this be a year of sustained, substantial enforcement actions and efforts relative to unapproved marketed drug products after a very slow year or will this action be the exception rather than the rule for 2014.