Source: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/01/index.html
Timestamp: 2017-09-22 15:36:04
Document Index: 19519630

Matched Legal Cases: ['§ 355', '§ 1301', '§ 1301', '§ 1301', '§ 1301', '§ 812']

FDA Law Blog: January 2014
FDA’s implementation of the Generic Drug User Fee Amendments of 2012 (“GDUFA”) and adherence to the triad of key aims laid out in the accompanying Performance Goals and Procedures – Safety, Access, and Transparency – have been a bit of a roller coaster ride for the generic drug industry, the Office of Generic Drugs (“OGD”), and even us.
It wasn’t too long ago that we were griping on this blog (see here) about a Manual of Policies and Procedures (“MAPP”) – MAPP 5200.3 – titled “Responding to Industry Inquiries with respect to Abbreviated New Drug Applications in the Office of Generic Drugs” that FDA published in September 2013 as part of the preparatory efforts in the lead-up to full GDUFA implementation beginning on October 1, 2014. Although the stated intent of the MAPP is to “clarif[y] the general principles for handling inquiries with respect to [ANDAs] from the authorized representative for an applicant with an ANDA submission (the authorized inquirer) by Regulatory Project Management (RPM) staff in [OGD]” we were concerned it represented what we called the “UFAization” of OGD (i.e., the process by which an FDA component, after the enactment of a User Fee Act, becomes focused on so-called process enhancements to meet goals and commitments at the expense – both literally and figuratively – of those who are subject to such user fees.)
We were a little more upbeat about news shared by FDA at the Generic Pharmaceutical Association’s (“GPhA’s”) 2013 Fall Technical Conference about GDUFA implementation, including year 1 accomplishments and the announcement that a committee – the GDUFA Steering Committee – had been put together to oversee GDUFA implementation (see our previous post here). We were even more encouraged when the news came out that the Department of Health and Human Services approved the reorganization of OGD into a “Super Office” and that a new reporting structure would be created, including the creation of a new Office of Generic Drug Policy to handle, among other things, Hatch-Waxman disputes (see our previous post here).
On the downside, we have heard some complaints about FDA’s enhanced ANDA refuse-to-receive standards reflected in recent guidance and less-than-helpful responses to Controlled Correspondence, though we have not focused on either topic in a blog post. And then there’s the issue of how OGD will handle the recent explosion in ANDA submissions, as reported by Bob Pollock at the Lachman Blog (see here).
But what we’re here today to announce is what can only be described as a massive and unprecedented undertaking on the part of OGD to address what seems to be an outpouring of concern about the perceived effects of MAPP 5200.3. In other words, OGD has heard industry’s concerns and wants to do something about it – at least to the extent the Office can do so.
In a recent memorandum to the Commissioned Corps (“CC”) Officers serving in OGD, OGD’s Acting Director, Kathleen Uhl, M.D., says that OGD’s “recent process changes, while critical to improving review efficiency, have made it harder for industry to assess the status of their submissions, and to plan the market launch of generic medicines that are important to industry and consumers alike.” As such, writes Dr. Uhl, CC Officers “will be placed in mission critical status until completion of a one-time, special initiative related to GDUFA implementation.” And what is this “special initiative”? “Beginning February 1,” writes Dr. Uhl, “OGD’s CC officers will conduct a complete inventory of all the original ANDAs in our queue, and provide each applicant with an update regarding the status of its ANDAs.”
That’s right, ANDA sponsors will be receiving, on a rolling basis, information on all of their respective original ANDAs (and amendments to them) – but not supplements – pending at the Agency. This covers ANDAs submitted to FDA pre-GDUFA and pending on October 1, 2012 (i.e., the backlog), and that are subject to the GDUFA goal of 90% action by the end of FY 2017. It also includes ANDAs submitted to FDA in the full year 1 (Fiscal Year 2013) and partial year 2 (Fiscal Year 2014) GDUFA cohorts. These two GDUFA cohort years have been referred to as the “GDUFA donut hole” because, other than first Paragraph IV submissions, there are no FDA performance goals associated with review and action on them. Performance goals take effect on October 1, 2014 (Fiscal Year 2015), when OGD has agreed to review and act on 60% of original ANDA submissions within 15 months from the date of submission, among other goals. Note, however, that action on an ANDA within 15 months does not necessarily mean approval of that application. More likely, OGD will be issuing Complete Response Letters reflecting full division-level review of deficiencies from all relevant review disciplines, including inspections. Certainly, that seems to be the trend – see here and here. This also means that once OGD issues a Complete Response Letter, and a sponsor responds, there may be another call from industry to gain some transparency into ANDA status.
Although ANDA sponsors will not be able to request prioritization of the ANDAs on their respective lists, FDA’s action goes a long way to give greater transparency to application status, and could help as companies plan for the future. As Dr. Uhl notes, “[t]he inventory and update goes above and beyond our negotiated GDUFA commitments. It represents an extra effort to improve transparency, and help stakeholders cope with some of the uncertainty and disruption created by GDUFA implementation.”
Thank you OGD for listening to your stakeholders and providing a greater level of transparency; and thank you CC Officers for dedicating your time to this special initiative!
Posted at 04:07 AM in Hatch-Waxman, Prescription Drugs and Biologics | Permalink | Comments (0)
Posted at 06:00 PM in Enforcement | Permalink | Comments (0)
Recent events have demonstrated that this case is indeed what this writer calls an old fashioned Park criminal prosecution. The government filed criminal charges under the FDC Act against company officials, without allegations that the defendants intended to violate the law and without a plea bargain that demonstrated that a misdemeanor prosecution was a settlement of more serious felony charges.
On January 28, 2014, the United States District Court for the District of Colorado sentenced the two defendants to five years probation, based on their guilty pleas to the six count criminal Information. They were also placed in home detention for six months, required to complete 100 hours of community service, and ordered to pay a total of $150,000 in restitution. The court did not impose any fine “because Defendants have no ability to pay a fine.”
On January 17, 2014, the government filed a somewhat remarkable “Sentencing Statement.” It argued that the relevant offense level for this case was 9. When a criminal case fits into the offense level of 9, a court must require some jail time unless it orders substitute measures such as home detention, under Sentencing Guideline 5B1.1. The government stated that it agreed with the United States Probation Office that the recommended sentence should be probation. The government explained that “any offense that results in 33-40 deaths [which deaths resulted from the sales of the adulterated canteloupes by defendants’ company] is a serious offense.” Nevertheless, “the seriousness of the offense is tempered in this case by the lack of a willful, intentional or knowing state of mind. These defendants were at worst negligent or reckless in their acts or omissions.”
The government then discussed what it described were mitigating circumstances, namely what the defendants did after they discovered that their company’s fruit was tainted. The government stated that the defendants: sought to voluntarily recall the fruit; through their counsel offered cooperation and assistance in the government’s investigation; and addressed the victims and their families “in an attempt to provide the victims a sense of comfort and closure,” waiving what the government called “constitutional protections in favor of addressing sensitive victim issues.”
The government also made a somewhat remarkable claim that it has already seen a significant difference in how food safety is viewed as a result of this prosecution. It asserted (without citation) that “A recognition that shoddy compliance with food safety standards and statutes potentially exposes those in the distribution chain to criminal liability has been taken seriously by the food industry in light of this prosecution.” That statement should be beneficial to the food industry in a variety of contexts.
It is interesting that the government did not explicitly ask for home detention or community service for the defendants even though the Court later imposed those requirements.
So what do we take away from this case:
This is perhaps the first recent case where the government has actually gone on record stating that it believed that defendants prosecuted under 21 U.S.C. 333(a) lacked any criminal intent. In most or all other recent cases the government has stood silent on whether a defendant prosecuted under this statute had any criminal intent;
Even conduct that leads to a substantial number of deaths will not necessarily warrant jail time;
Defendants can take remedial steps after the “crimes” have been committed which will substantially reduce the sanctions that the government will seek and that a court will impose;
For better or worse, the Park Doctrine is indeed alive, at least to the extent that it was applied in this case; and
Based on comments made by the government in its Sentencing Statement, it appears that the prosecutors concluded that when deaths occur, the government believes it is obliged to seek criminal sanctions regardless of whether the people prosecuted have any wrongful intent.
Posted at 02:01 PM in Enforcement | Permalink | Comments (0)
By Delia A. Deschaine –
Various members of industry recently joined together in filing a citizen petition with FDA. Citizen Petition, Docket No. FDA-2013-P-1711 (hereinafter “Citizen Petition”). The Citizen Petition responds to a statement made by CDER Director, Janet Woodcock, M.D. in October 2013 that FDA intends to issue a scientific and medical evaluation and recommendation that DEA reschedule all hydrocodone combination products from their current placement in Schedule III to Schedule II. The petitioners argue that reclassifying all combination hydrocodone products is inappropriate for myriad of public policy reasons. Thus they request that FDA instead recommend DEA reclassify only hydrocodone combination products that contain hydrocodone bitartrate in a strength of 5 mg or higher. Citizen Petition at 2. While the petition is brief, it touches on several critical points that FDA and DEA will likely consider in determining whether to move forward with the rescheduling.
To name a few points, the petitioners assert that reclassifying all hydrocodone products will have “numerous unintended consequences, including depriving vulnerable patient populations of access to critically-needed pain medications.” Id. at 2. The petitioners estimate that nearly 100 million Americans suffer from chronic pain and, thus, require opioid treatment for long periods of time. Id. at 3. These patients will also be negatively impacted by the reclassification of all strengths of hydrocodone products, as the drug will become more costly to acquire, and, therefore, less available. See id. Further, the petitioners state that the “upscheduling of hydrocodone combination products would require patients to see their doctor for office visits with greater frequency simply to refill a prescription,” and “[a]s FDA could imagine, such a policy change would impose heavy burdens . . . on patients, caregivers and the health care system . . . .” Id. (Unlike substances in Schedule III of the Controlled Substances Act, prescribers are not permitted to write refill prescriptions for controlled substances listed in Schedule II.)
The Citizen Petition is not the first response to the proposal to reclassify hydrocodone combination products, and likely not the last. FDA and DEA have battled for years over the appropriate placement of hydrocodone combination products. See prior post, here. The issue most recently attracted public attention in April 2012, when Congress declined to legislatively reclassify hydrocodone combination products. See prior post, here. Instead, Congress ordered FDA to convene a working group to discuss the risks and benefits of reclassification, which it did in January 2013. Although FDA signaled its intent to issue a recommendation that DEA move forward with the reclassification by the end of the year (a departure from the position it took a few years ago, as petitioners noted), no public statement has been made that FDA did so. We note, however, that FDA is not required to publish its recommendation in the Federal Register and historically has not done so. For that reason, the four-page Citizen Petition may flush out whether FDA has or intends to issue its recommendation soon. (Pursuant to 21 U.S.C. § 355(q), FDA must respond to a citizen petition within 150 days if the petition may delay the approval of a pending 505(b)(2) or Abbreviated New Drug Application.)
Nevertheless, as the petitioners recognize, a DEA reclassification would likely have broad-sweeping implications for all members in the pharmaceutical chain of distribution. See prior post, here. These costs include compliance with the physical security requirements imposed on registrants for Schedule II controlled substances (i.e., that they be physically stored in secure cabinets or vaults (depending on the amount). See 21 C.F.R. §§ 1301.71(a), 1301.72. Currently, many pharmacies store hydrocodone combination products in safes or spread out shelves with other prescription drugs, and wholesalers store those products in cages (as opposed to vaults for Schedule II substances), as permitted by DEA. Id. § 1301.72. If hydrocodone products are reclassified in Schedule II, many pharmacies and wholesalers will need to alter their storage and security controls due to the widespread use and thus supply of these medications. See id. § 1301.71(c) (requiring registrants to “expand[] or extend[]” their physical security controls “when [they] become inadequate as a result of a controlled substance being transferred to a different schedule”). This may include vault construction or alteration which is difficult and costly, given DEA’s precise regulatory specifications. Id. § 1301.72.
Because Schedule II prescriptions may not be refilled, the reclassification of hydrocodone would also likely impose additional costs on practitioners who routinely prescribe combination hydrocodone to patients requiring long-term opioid treatment. Those costs may include administrative expenditures (e.g., supplies and support staff) necessary to handle an increased frequency of in-office visits by their patients. Payers, such as Medicare, Medicaid, and private insurance, bear some of the burden of subsidizing these costs. See Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2014, 78 Fed. Reg. 43,282 (July 19, 2013) (discussing how administrative expenditures factor into the Medicare physician fee-for-service rates).
On balance, the petitioners argue, reclassifying only certain higher strength products serves to “protect[] vulnerable patient populations which rely on such medication without sacrificing the ability of DEA to target enforcement of drug products likely to be abused (i.e., products in 5 mg strength and above).” Citizen Petition at 3-4.
The hydrocodone rescheduling petition relates to the many initiatives that FDA has recently taken to address concerns regarding the widespread misuse and abuse of opioids. See, e.g., prior post, here. (discussing FDA’s new labeling for all extended release opioid drugs and biologics). Despite these efforts, FDA recently came under scrutiny by lawmakers and state attorneys general for its approval of a single-entity hydrocodone drug (making it the first available U.S. hydrocodone drug in Schedule II), without requiring the drug to possess “abuse-deterrent technology.” See prior post, here. FDA did so despite finding earlier that year that drug manufacturer, Purdue, had withdrawn Oxycontin for safety or efficacy reasons, in the wake of FDA’s approval of a tamper-resistant formula for that drug. Id. FDA reasoned that its policy is to consider whether abuse-deterrent technology is necessary to ensure adequate safety of a drug on a “product-by-product” basis. Id. In response, The Pharmacists Planning Service, Inc. (“PPSI”) filed a petition with FDA (Docket No. FDA-2013-P-1606) requesting that FDA add “drug-abuse deterrent technology to all hydrocodone schedule II products.” The petition listed concerns regarding the abuse of opioids generally, and, specifically, hydrocodone. Id. Interestingly, PPSI stated that “[it] has encouraged the FDA reschedule this hydrocodone/apap to schedule II.” Id. at 2.
For now, we wait with curiosity to see whether, and how, FDA considers the arguments made in these petitions in issuing its scheduling recommendation to DEA.
Posted at 09:16 PM in Controlled Substances, Drug Enforcement Administration | Permalink | Comments (0)
On December 26, FDA sent Warning Letters (here and here) to Accera, Inc. and NVN Therapeutics. Accera Inc. markets a product, Axona, as a medical food “for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s disease,” whereas NVN Therapeutics markets GlucoreinTM PCOS as a medical food for the “dietary management of Polycystic Ovarian Syndrome ("PCOS") by reducing the incidence of metabolic syndrome and insulin resistance.” FDA alleges that these products are misbranded as medical foods because, according to FDA, there are no distinctive nutritional requirements or unique nutrient needs for individuals with mild to moderate Alzheimer’s disease and for PCOS.
Why is this worth a blog post, you ask? To our knowledge, these are the first two Warning Letters in which FDA asserts yet another requirement for medical foods. Under FDA’s “narrow interpretation,” medical foods must not only meet all the requirements of FDA’s regulation, 21 C.F.R. 101.9(j)(8), they also must be intended for “the patient who is seriously ill or who require use of the product as a major component of a disease or condition’s specific dietary management.” Although the Agency mentioned this requirement in the 2007 guidance and the draft 2013 guidance (see our previous post here), so far, the Agency had not mentioned this limitation in Warning Letters. More important, the Agency has not provided any authority for adding this requirement.
Posted at 02:18 AM in Enforcement, Foods, Foods and Dietary Supplements | Permalink | Comments (0)
Biosimilars (or follow-on biologics) are a hot topic these days – and getting hotter – whether one talks about FDA’s draft guidance documents (see here), battles brewing in state legislatures around the country concerning substitution (see here), the flurry of citizen petitions submitted to FDA concerning biosimilar naming (see here), controversy concerning the “patent dance” procedures of the Biologics Price Competition and Innovation Act of 2009 (see here), or the applicability of the BPCIA to older biological products (see here).
On February 4, 2014, the Federal Trade Commission (“FTC”) will hold a workshop addressing some of these issues: “Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition.” (The final agenda for the February 4th workshop was announced earlier this week.) And just two days later, on February 6, 2014, from 12:00-1:00 PM EST, experts from Hyman, Phelps & McNamara, P.C. and Dechert LLP will discuss the implications of and issues with the new biosimilar approval process created by the BPCIA and other major takeaways from the FTC workshop. Topics to be covered during the February 6th webinar will include: (1) Current status and next steps for the FDA’s implementation of a biosimilar approval process; (2) Major takeaways from the FTC’s February 4 workshop on biologics; and (3) Intellectual property issues in the run-up to the first biosimilar approval.
Registration for the webinar is free and can be made here. Webinar speakers include Hyman, Phelps & McNamara, P.C.’s James C. Shehan and Dechert LLP’s Daniel M. Becker, M.D., Mike Cowie, and George G. Gordon. Please confirm your webinar attendance by February 5, 2014. Further details, including how to connect to the webinar, will be provided closer to the program.
Posted at 02:12 AM in Prescription Drugs and Biologics | Permalink | Comments (0)
In a concurrently issued press release, FDA touted the summary as “extremely informative” and reiterated that the agency is “especially concerned with products that may be attractive and readily available to children and adolescents, without careful consideration of their cumulative impact.” FDA also noted that it continues to investigate adverse event reports for energy drinks and other caffeinated products, with public safety as the agency’s “top priority,” and that the new online adverse event reporting system for dietary supplements “will make it easier for the FDA to detect dietary supplements that pose risk for a range of reasons, including excessive levels of caffeine.”
Posted at 09:24 PM in Dietary Supplements, Foods, Foods and Dietary Supplements | Permalink | Comments (0)
FDA has issued a new draft guidance on the custom device exemption. Comments are due by March 17, 2014. This schedule puts FDA on track to finalize the guidance by July 9, 2014, as required under section 617 of the Food and Drug Administration Safety and Innovation Act (“FDASIA”) (Pub. L. 112-144). (See our FDASIA summary here at pages 41-42.)
What is the custom device exemption? It is a long standing provision in Section 520(b) of the Federal Food, Drug, and Cosmetic Act (“FDCA”) that allows device manufacturers to distribute devices designed to accommodate unique patient conditions without premarket application (“PMA”) approval under Section 515 of the FDCA. The exemption does not relieve the manufacturer of the usual post market regulatory requirements that apply to medical devices.
Congress revamped the custom device exemption in FDASIA. Some of the changes were more clarifying than substantive, but a few new concepts were added. Those who need to consider the applicability of a custom device exemption should review the amended statute and draft guidance and ignore the existing regulation (21 C.F.R. § 812.3(b)), which has not been updated.
The following is a paraphrase of the custom device requirements in the revised statute. For a device to qualify, all of these requirements must be met:
It is created or modified to comply with the order of a physician or dentist.
In order to comply, the device necessarily deviates from an otherwise applicable premarket approval requirement in Section 515 of the FDCA.
It is not generally available in finished form through labeling or advertising for commercial distribution in the U.S.
It is designed to treat a unique pathology or physiological condition that no domestically available device can treat.
It is intended to meet the needs of a physician or dentist in treating a patient, or will be used by the patient on order of the physician or dentist.
It is assembled by components or manufactured and finished on a case by case basis to accommodate the unique needs of the physician/dentist or patient.
It may have common standardized design characteristics, material and chemical composition, and manufacturing processes as commercially distributed devices.
If a device meets these requirements it may be distributed as a custom device, with three further limitations:
The condition being treated must be sufficiently rare that a clinical study is impractical. (This limitations codifies an interpretation that FDA has long applied.)
Multiple units of the device may qualify for the exemption, but no more than five units per year.
The manufacturer must annually notify FDA if it is producing custom devices.
FDA’s guidance does a good job of explaining how the agency will enforce these requirements. We will not reiterate the entire guidance here, since it is largely self explanatory. The flow chart on page 19 of the draft guidance is especially useful.
A few points are worth highlighting:
FDA interprets the five unit per year limitation to exclude extra devices provided in different sizes if the unused devices are returned. Also, multiple devices for multiple anatomical locations (e.g., bilateral hip replacements) will count as one unit if used in the same reporting year. [Draft Guidance, lines 229 264.]
FDA explains that the a device is either patient-centric or physician/dentist centric. The distinction is between a device that treats a rare patient need and leaves the practice with the patient versus a device that fulfills a special need in the physician/dentist practice that stays with the practice. [Draft Guidance, lines 279 285.] It is left unexplained what types of devices might fulfill a physician/dentist special practice need. It would have been helpful if examples had been provided; all of the examples appear to relate to patient needs.
FDA reiterates its long standing interpretation precluding “patient specific” or “patient matched” devices from qualifying for the custom device exemption. These are devices “in which ranges of different specifications have been approved or cleared to treat patient populations that can be studied clinically. . . . The final manufacturing of these devices can be delayed until the physician provides imaging data or other information . . . to finalize the specifications of the device within . . . cleared or approved ranges. As a result, the device is specifically tailored for the patient.” [Draft Guidance, lines 329 343.] Thus, contact lenses or customizable orthopedic implants would typically not qualify for the custom device exemption.
A final stylistic point: the draft guidance continues FDA’s increasing practice of providing guidance through lengthy question and answer sections. This practice is somewhat helpful in ensuring that specific questions are answered. But the use of lengthy questions in headings and subheadings makes it more difficult to find information, not less so. FDA should revert to using key word topic headings and subheadings; these are a tried and true way of showing the reader where information may be found.
Posted at 03:29 AM in Medical Devices | Permalink | Comments (0)
Posted at 11:48 PM in Enforcement | Permalink | Comments (0)
In a Januarry 22, 2014 letter to FDA Commissioner Margaret Hamburg, M.D. signed by 28 members of Congress, lawmakers express “grave concerns” about FDA’s November 2013 proposed rule to allow generic drug manufacturers to independently update product labeling (with respect to product safety) through the changes being effected (“CBE-0”) supplement process that is currently only available to brand-name drug manufacturers whose products are approved under an NDA. As we previously reported, the proposal is quite clearly intended to undercut generic drug labeling preemption arguments and was made in response to various U.S. Supreme Court rulings, and in particular the Court’s ruling in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).
“We strongly believe that such a rule would conflict directly with the statute, thwart the law’s purposes and objectives, and impose significant costs on the drug industry and healthcare consumers,” write the lawmakers, who request that FDA “explain and reconsider this departure from decades of settled practice.” House Energy and Commerce Committee Chairman Fred Upton (R-MI) reiterated this message in a press release announcing the letter to FDA. (A similar press release was issued by Senator Lamar Alexander (R-TN), the senior Republican on the Senate health committee.) The letter goes on to note that a bedrock principle of generic drug approval has been the same labeling requirement, which FDA has adhered to for decades and that “Congress has also embraced . . . , as we have declined to change it in every food and drug law we have passed since 1992.”
But even putting the same labeling requirement to one side for a moment, the lawmakers say that FDA’s proposal threatens to undermine the purpose of the Hatch-Waxman Amendments:
Allowing generic manufacturers to unilaterally change their labeling means potentially dozens of drugs that are chemically and biologically identical might nonetheless bear different safety information, confusing patients and prescribers alike. The labeling on the generic products should be ide tical to the labeling on the branded product so providers and patients are comfortable with the risks and benefits of the product they are using regardless of the name of the company on the bottle or vial.
In a move that is likely to provide much fodder for comment on FDA’s proposal (as well as in any litigation that might ultimately result if FDA finalizes the proposal), the lawmakers ask that FDA respons to a series of questions by Febryary 5, 2014:
1. For the period of time after a generic drug has submitted a CBE-0 supplement, please explain how the generic drug’s label will be “the same as the labeling approved for the requirements included in sections 505(j)(2)(A)(i)-(v) of the Hatch-Waxman Act extend beyond the date of approval?
2. Please explain the benefit of having proposed label changes published on a public website before FDA consideration, undermining FDA’s current role as the gatekeeper and deciding authority for changes to a drug’s label.
3. Please provide the names of any executive branch employees outside the FDA who were involved in the decision to proceed with this proposed rule or who participated in drafting or reviewing it.
4. What is FDA’s policy on when an adverse event needs to be listed on the label? Are there standards around the prevalence or severity of the adverse event that are necessary before it rises to a labeling change?
5. What is the expected cost to the FDA to review the CBE-0 submissions in a timely manner and establ sh and update the website, and from where does the FDA propose drawing resources to meet these costs? How will the agency prioritize submissions and what is the estimated time or review?
6. Please describe in detail how FDA arrived at the estimated cost orthe rule of $4,237 to $25,852 per year and estimates it will receive 20 CBE-0 supplements annually from approximately 15 ANDA holders. Please explain how the agency derived these estimates. Did FDA conduct any analysis of how long it takes a manuhlcturcr to prepare a CBE supplement and how much it costs? Did FDA conduct any analysis of what it will cost manufacturers to institute new procedures for monitoring safety and enectivencss of drugs? Did FDA conduct any analysis of the effect the proposed rule will have on drug prices? Please provide all documents and communications regarding the cost-benefit analysis.
7. Generic drug manufacturers can currently propose labeling changes with FDA as a result of newly acquired safety information. Please provide statistics for how many times this is done in comparison to brand name manufacturers and the current causes of any delay when using that process. Please provide any evidence that would indicate generic drug manufacturers are not submitting required adverse event reports or otherwise not meeting their post-market surveillance requirements[.]
8. The proposed rule notes a 2010 study of FDA safety-relatcd drug labeling changes that found the me ian time from initial approval of the drug product to label change was 11 years. Please provide this study and all support ing documentation to the Committee(s). Please also provide statistics showing how long it takes FDA to make a decision once a label change is suggested.
9. Please explain why the prior approval supplement process alone cannot be used effectively to change generic and brand drug labels, and the current causes of any delay when using that process. Please provide any evidence that would indicate generic drug manufacturers are not updating their label upon FDA approval of a change to the label of the reference brand drug.
10. As an alternative approach, did the FDA consider permitting generic drug manufacturers to use a modified CBE process by which the agency has an opportunity to assess a proposed labeling change before introducing it into the market? What does the agency believe would be the pros and cons of using this approach as opposed to the CBE-0? Did the agency conduct a cost benefit analysis of such an approach?
11. Did the agency consider the impact the proposed rule would have on over-the-counter (OTC) drugs? If so, please submit any such analysis and explain how FDA envisions the proposed regulation applying to OTC drugs.
The letter closes on a strong note expressing the lawmakers’ disdain of the FDA proposal and the process undertaken by the Agency to move forward with a “solution” to the “problem” resulting from the U.S. Supreme Court’s ruling:
Indeed, that’s exactly what the last line of the Court’s decision in PLIVA said: “Congress and the FDA retain the authority to change the law and regulations if they so desire” (emphasis added).
Posted at 11:01 PM in Hatch-Waxman, Prescription Drugs and Biologics | Permalink | Comments (0)