The US Food and Drug Administration (FDA) has released the text of a newly proposed rule that would give the agency the authority to administratively detain human and veterinary pharmaceutical products it believes are either adulterated or misbranded.
The rule comes out of the Food and Drug Administration Safety and Innovation Act (FDASIA), a law passed on 9 July 2012 containing a massive number of reform provisions. Among them was Section 709, "Administrative Detention," which ordered FDA to promulgate a final regulation within two years of the passage of the law regarding the detention of both drugs and devices.
In particular, the law adds "drugs" to the definition of Section 304(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act), which gives FDA the authority to detain "for a reasonable period which may not exceed 20 days" any product it believes to be misbranded or have been manufactured outside of conformance with quality regulations (i.e. adulterated). An additional 10 days of detention may be authorized if additional time is needed to initiate enforcement actions, the statute adds.
The intent of the section is to permit FDA to take proactive action against questionable products, thereby allowing it to better protect the pharmaceutical supply chain. Without the authority, it would need to launch an investigation regarding the origins or status of a product, all the while the product would be free to proliferate around the country. As a result, by the time FDA obtained proof or permission to detain a product, consumers might already have been injured.
A Consultation Process
In April 2013 FDA began to solicit comments regarding the impending rule, establishing a docket for any preliminary comments. This process was required under Section 709 of FDASIA.
Despite the statutory requirement, only one entity, the Generic Pharmaceutical Association (GPhA) commented, saying only that it would "like to continue to have dialogue with the FDA as [it develops] this very important draft guidance." It is unclear as to whether the term "draft guidance" was a typo, or a misunderstanding on the part of GPhA regarding the full effect of the notice. FDA said it considered GPhA's letter "non-responsive" and did not consider it.
Regardless, the 30-day comment period FDA established for preliminary comments expired on 9 June 2013, and FDA is now out with its proposed rule on administrative detention.
FDA explained that "the primary public health benefits from adoption of the proposed rule would be the value of the illnesses or deaths prevented because the Agency administratively detained a drug it has reason to believe is adulterated or misbranded."
Detention Proceedings and Appeals
The rule itself establishes exactly how FDA would go about detaining a product. Under Section 1.501(b) of the proposed rule, detention proceedings would begin when an authorized FDA representative conducting an inspection under Section 704 of the FD&C Act "has reason to believe that a drug…is adulterated or misbranded." As in the existing statute, this detention should not exceed 20 days unless an additional 10 are needed to bridge a gap through legal proceedings. Such an extension could only be authorized by a district director.
Under 1.501(d), detention orders must be issued in writing, signed by an authorized FDA representative, and issued to the owner, operator or agent in charge of the place where the pharmaceutical products are presently located. Copies of the detention order much be provided to the owner of the drug if the present owner of the drug cannot be determined. If the products are not in a facility, but are instead in a vehicle or mobile carrier, a copy of the notice must be given to the shipper of record and to the owner of the vehicle.
Under 1.501(b)(3), the order must contain a statement of the detention period, a statement regarding the reasons for detainment, the location of the drugs, a statement ordering that the drugs not be moved or tampered with, an identification of the detained drugs, the detention order, period of detention, and information regarding the process for appealing and contacting FDA.
All detention orders must also be approved by the local FDA district director in writing, though oral approval may be obtained in extraordinary circumstances so long as the order is confirmed in writing "As soon as possible."
Detained drugs will be affixed with a label that the drugs are detained by the US government, and that altering or tampering the drugs subjects an individual to fines, imprisonment or both.
Movement, Destruction and Release
Section 1.501(g) allows the owner of a detained drug product to appeal the detention order, which must be done within five working days of initial receipt of the order. Any hearing must be conducted within 5 working days after the appeal is filed.
Drugs are generally not to be moved, but several exceptions exist to this rule. For example, if the detained drugs are not in final form for shipment, they may be moved within an establishment (i.e. the manufacturing facility) to complete the work needed to put them in final form. FDA must be notified of this movement, and the drugs must be segregated from other product and not moved thereafter. In addition, FDA may issue written permission to move a detained drug product if the movement will serve to destroy the drug, preserve the drug, allow the facility to continue operating or bring the drug into compliance with regulations.
If FDA determines that the detained product is adulterated or misbranded, it "may initiate legal action against the drugs or the responsible individuals, or both, or request that the drugs be destroyed or otherwise brought into compliance with the FD&C Act under FDA's supervision," the rule states. Otherwise, as the end of the 20/30 day period, FDA will issue a "Detention Termination" notice releasing the drugs to the owner, who must retain all records of the detention for two years.
Effects and Dates of Effect
The net annual benefits would be relatively small - just $591,480 per year on the high end, to FDA's estimation - and FDA said it believed the rule would not have a significant economic impact on many small businesses. FDA said it believed it would detain between zero and 20 products per year under the rule.
The rule is set to go into effect 30 days after its final publication in the Federal Register. It is now open to 60 days of public comment.
FDA Proposed Rule