Re: Guidance for Industry Fees for Human Drug Compounding Outsourcing Facilities Under The Federal Food, Drug and Cosmetic Act

Transcription

1 May 30, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane, Room Rockville, Maryland [Docket No. FDA-2014-D-0329] Re: Guidance for Industry Fees for Human Drug Compounding Outsourcing Facilities Under The Federal Food, Drug and Cosmetic Act Dear Sir or Madam: Thank you for the opportunity to submit our comments on FDA s Draft Guidance regarding industry fees for Outsourcing Facilities under the Food, Drug and Cosmetic Act. As FDA considers finalizing the proposed new guidance for outsourcing facilities, the International Academy of Compounding Pharmacists (IACP) appreciates the opportunity to share our perspectives and to work with FDA in the future on this very important issue. IACP is an association representing more than 3,600 pharmacists, technicians, students, and members of the compounding community who focus on the specialty practice of pharmacy compounding. Compounding pharmacists work directly with prescribers including physicians, nurse practitioners and veterinarians, to create customized medication solutions for patients and animals whose healthcare needs cannot be met by manufactured medications. ISSUE Contrary to the clear language and intent found within the Drug Quality and Security Act dictating that no facility will be deemed a registered outsourcing facility until the facility has paid the establishment fee in full, FDA has posted on its website a list of all facilities expressing intent to register as an outsourcing facility even where the entity has not paid its establishment fee. INTERNATIONAL ACADEMY OF COMPOUNDING PHARMACISTS Corporate Offices: 4638 Riverstone Blvd. Missouri City, Texas Washington DC Offices: 1321 Duke Street, Suite 200 Alexandria VA

2 May 30, 2014 Page 2 In addition, even where the facility has not paid the establishment fee and is thus not deemed a registered outsourcing facility under the DQSA, FDA continues to portray these entities to the public as registered outsourcing facilities and encourages hospitals, States, and other purchasers to only conduct business with facilities listed currently on the FDA website as registered outsourcing facilities by sending letters to these stakeholders promoting those facilities currently listed as registered outsourcing facilities on the FDA website. PROPOSED GUIDANCE Page 1, Lines Once an entity has elected to register as an outsourcing facility, it must pay certain fees to maintain its status as an outsourcing facility. Page 2, Lines Beginning in fiscal year (FY) 2015, outsourcing facilities that elect to register with FDA must pay an annual establishment fee. Page 3, Lines Upon receiving registration information from a facility that elects to register as an outsourcing facility, FDA will send an invoice for the fee (see Section III.E.1 for information on invoicing and instructions for submitting payments). For a given FY, an outsourcing facility will not be considered registered for purposes of section 503B(b) until the annual establishment fee is paid. Page 3, Lines Outsourcing facilities that registered before October 1, 2014, do not have to pay a fee for FY To maintain their status as outsourcing facilities in FY 2015, however, those entities will have to register during the FY 2015 registration period (October 1 - December 31, 2014) and pay the relevant fees in accordance with the instructions in Section III.E.1 of this guidance. Failure to pay the fee by December 31, 2014, will result in an entity losing its status as an outsourcing facility. FDA will remove the entity from the list of registered outsourcing facilities, and drugs compounded at the facility will no longer qualify for the exemptions under section 503B(a), 90 unless and until the firm reregisters and pays all required fees. Page 3, Lines Because an entity must complete payment of the registration fee before it will be considered registered for purposes of section 503B(b), drugs compounded in that facility prior to registration and payment of fees will not qualify for the exemptions for products compounded by registered outsourcing facilities under section 503B(a).

3 May 30, 2014 Page 3 COMMENT Page 7, Lines Because entities will not be considered to be registered as outsourcing facilities until payment is received, FDA suggests that entities pay the invoiced amount immediately upon receiving the invoice. If an entity does not pay the full invoiced amount within fifteen calendar days after FDA issues the invoice, FDA will consider the submission of registration information to have been withdrawn and adjust the invoice to reflect that no fee is due. The DQSA clearly states that no facility may be deemed a registered outsourcing facility until that facility has not only elected to register as such but has in addition paid the establishment fee in full that is owed. Thus, it is the clear intent of Congress that before portraying these entities to purchasers, patients, healthcare providers, and the public as a whole as registered outsourcing facilities, these facilities will not only express interest in registering as such but will also validate the intent to register by paying the establishment fee in full. Despite this clear intent and the clear language found within the DQSA, FDA continues to post all facilities that have solely expressed interest in registering as an outsourcing facility on its website. To date, the FDA website lists 42 facilities as registered outsourcing facilities. Out of the 42 facilities listed on the FDA website as Firms Registered As Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (as updated as of 5/16/14), 17 of these facilities have not been inspected by the FDA. In addition, out of the 42 facilities currently listed on FDA s website as registered outsourcing facilities, FDA only estimates that approximately 20 of these outsourcing facilities will pay the required establishment fee. Specifically, in the Notice accompanying this guidance, FDA states We estimate that annually a total of approximately 20 outsourcing facilities ( no. of respondents in table 1, row 1) will pay to FDA approximately 20 establishment fees ( total annual responses in table 1, row 1) as described in the draft guidance. We also estimate that it will take an outsourcing facility approximately 0.5 hours to prepare and submit to FDA each establishment fee ( average burden per response in table 1, row 1). 1 IACP is very concerned that despite the clear language and intent found within the DQSA, FDA continues to list all facilities expressing desire to register on the FDA website as registered outsourcing facilities even where FDA has not inspected almost half of these facilities and is only estimating that half (20) of these facilities will actually pay the establishment fee. 1 See FDA-2014-D

4 May 30, 2014 Page 4 Furthermore, IACP has previously expressed in letters to FDA and will take this opportunity to continue to express strong concerns with FDA s actions in promoting these facilities by sending mass letters to hospitals, States, purchasers, etc. stating that all stakeholders should only conduct business and thus receive products from those facilities deemed a registered outsourcing facility as identified by the FDA website. RECOMMENDATION FDA should adhere to the clear language and intent found within the DQSA that in order to be deemed a registered outsourcing facility a facility must express interest in registering as such and pay the establishment fee in full. Until such fees have been paid, FDA should cease causing mass confusion amongst providers, healthcare entities, patients, States, and the public as a whole by promoting facilities to these stakeholders as superior to 503A pharmacies even where it is premature to deem these facilities as outsourcing facilities where FDA only estimates half (20) of the current facilities listed as registered outsourcing facilities will actually pay the establishment fee to continue to operate and be recognized as a registered outsourcing facility. IACP finds FDA s actions irresponsible and not in the best interest of the public good in disregarding clear Congressional intent within the DQSA and promoting all facilities expressing an interest in registration even where FDA itself has acknowledged that almost half of the identified facilities have not been inspected and almost half will not pay the establishment fee. ISSUE FDA estimates in the notice accompanying this guidance that only 20 of the current 43 facilities identified by FDA as registered outsourcing facilities will pay the required establishment fee in full. While the agency lists and continues to promote those 43 facilities as registered outsourcing facilities, it also estimates that more than half of those will not pay the required establishment fee. Additionally, FDA provides guidance as to the consequences these facilities will face for not paying the establishment fee. As such, FDA does not include an opportunity for these facilities to decline to operate as outsourcing facilities and identify themselves as 503A pharmacies but instead dictates that all of these facilities will be deemed in violation of the New Drug requirements and in possession of misbranded drugs until these facilities pay the establishment fee. PROPOSED GUIDANCE Page 8, Lines An entity that does not pay its adjusted annual establishment fee for a given FY will not be considered registered as an outsourcing facility under section 503B of the FD&C Act for that FY. The facility will be considered registered, for purposes of 503B(b), when it pays the total adjusted annual establishment fee for that FY.

5 May 30, 2014 Page 5 COMMENT Outsourcing facilities that registered in FY 2014 and wish to maintain their status as an outsourcing facility in FY 2015 must register during the FY 2015 registration period, which lasts from October 1, 2014, to December 31, Failure to register and complete payment by December 31, 2014, will result in the loss of status as an outsourcing facility on January 1, Entities that submit registrations outside of the annual registration period must pay all relevant fees to be deemed registered; failure to pay fees will result in the facility being deemed not 288 registered for purposes of 503B(b). Page 9, Lines All drugs manufactured, prepared, propagated, compounded, or processed by a facility that has not paid the full amount of the required establishment fee or any applicable reinspection fee, will be deemed misbranded under section 502 of the FD&C Act. Such drugs will continue to be deemed misbranded until the fees owed by that facility have been paid in full. The facility cannot distribute misbranded drugs in interstate commerce. In addition, because one of the conditions of being an outsourcing facility is the payment of fees, drugs compounded in a facility that has failed to maintain its status as an outsourcing facility are also considered to be unapproved new drugs subject to the premarket approval requirements of section 505 of the FD&C Act. IACP has strong concerns that even where FDA is estimating that more than half of the facilities currently expressing interest in registering as outsourcing facilities, FDA has not detailed a process for these facilities to re-identify themselves as 503A pharmacies. Many instances could arise where a pharmacy finds itself in a position that it does not have the resources to comply with the continuous guidance that FDA is putting out governing OFs. FDA has yet to finalize a single guidance for 503A pharmacies or 503B outsourcing facilities. FDA is only in the preliminary state of releasing guidance for the industry and has stated publicly most recently during the Senate HELP hearing in response to Senator Alexander s questioning, that the Agency intends to release additional standards that are not cgmps to govern 503B outsourcing facilities. FDA has not produced lists of bulk ingredients that may be used by 503A and 503B facilities during compounding, do not compound lists due to demonstrable difficulty, and has just recently began the process of forming an advisory committee to oversee all these efforts. With so much uncertainty due to the lack of guidance from FDA and lack of input stakeholders are being allowed to provide to FDA, IACP is very concerned that FDA while promoting OFs to stakeholders and incentiving registration by waiving the establishment fee until FY 2015, the reporting fees until two months after registration, FDA has provided very little draft guidance and no final guidance to 503A pharmacies and 503B outsourcing facilities.

6 May 30, 2014 Page 6 With comments made by FDA during the Senate HELP hearing that another standard is being produced that OFs will be held as required to comply with opposed to cgmps but providing no guidance as to what the standard will resemble and soliciting no input from stakeholders in the drafting of such standards, FDA has caused mass confusion as to what standards OFs will even operate under. As such, IACP is very concerned that pharmacies are looking at the mass confusion within the marketplace and deciding not to register as an OF based on the certainty around the standards they will be held accountable or are registering and once the guidance is actually produced by FDA will seek to return to operating as a 503A compounding pharmacy. As such, it is alarming that FDA has not provided a pathway for these facilities to return to operating as a 503A pharmacy. RECOMMENDATION FDA should outline a clear process for facilities expressing interesting in registering as an OF to return to operating as a 503A pharmacy. These facilities should not be held liable for violating New Drug requirements and placing misbranded drugs into the marketplace where they simply wish to re-identify and operate as a 503A pharmacy and thus be removed from the FDA website as a registered outsourcing facility and cease operations as such. By not clearly outlining a pathway for these facilities to do such, FDA is creating an environment where facilities are being encouraged to express interest in registering as an outsourcing facilities even where FDA has failed to produce any final guidance or standards of quality for these outsourcing facilities and intends to hold them in violation of the FDCA New Drug and Misbranded requirements. ISSUE FDA failed to correlate the deadline to submit a request for a small business reduction with the deadline to comment on the small business reduction. The deadline for facilities to submit a request to FDA for a small business reduction for the outsourcing facility establishment fees was April of 2014 and will continue to be April of each FY. However, this guidance solicits feedback on the small business reduction. Thus, stakeholders were not allowed to submit comments and concerns with the small business reduction prior to the deadline for submitting their request to receive the small business reduction. PROPOSED GUIDANCE Page 6, Lines Entities that seek a small business reduction of the annual establishment fee must make a request for such a reduction by April 30th of the year preceding the fiscal year for which the entity is seeking a reduced fee.

7 May 30, 2014 Page 7 COMMENT Page 7, Lines FDA will accept small business reduction requests until April 30th of each year, and intends to advise the requesting entity of its decision within 60 calendar days of receipt of the request. FDA intends to send a letter to the entity, via (or regular mail if the request was by regular mail), notifying it of FDA s decision. Entities granted a reduction should maintain a copy of the letter for their records. IACP continues to have strong concerns that FDA is not soliciting adequate input from stakeholders in the form of timely comments that will be considered for real edits to the draft guidance and meetings with stakeholders. FDA continues to decline every invitation to meet with IACP and our members. IACP also has strong concerns that in previous notices, FDA has only estimated that only 10 OFs will request the small business reduction and out of these 10, FDA estimates only one OF will actually receive the small business reduction. RECOMMENDATION FDA should take all comments and concerns submitted toward the small business reduction into account and open back up the period of time to request the small business reduction. FDA should not allow such comments and concerns to go unheard by setting the deadline for requesting the small business reduction prior to the deadline for submitting comments on the small business reduction. FDA should also not require such a rigorous process for requesting the small business reduction that it acts a barrier for OFs. Stakeholder input is vital not only on this topic but on the entire implementation of the DQSA. FDA has failed to allow such input declining all meetings with stakeholders while providing no final guidance and no indication as to the rules these that OFs will be operating under. It is essential that FDA allow more stakeholder input in the implementation of the DQSA and such input does not solely serve as a way to check the box but provides a real opportunity for stakeholders to provide insight into the very industry and guidelines that they will be operating under.

8 May 30, 2014 Page 8 CONCLUSION Thank you for the opportunity to submit our comments and IACP looks forward to working with the FDA in the future on this very important issue. Sincerely, David G. Miller, R.Ph. Executive Vice President & CEO c: IACP Board of Directors