Articles Posted in Legislation

Thumbnail image for Thumbnail image for Thumbnail image for FDA.jpegLast week, the U.S. Food and Drug Administration published the Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022.  Commonly referred to as the “goals letter” or “commitment letter,” the publication represents discussions among FDA, the regulated industry, and public stakeholders regarding reauthorization of the Biosimilar User Fee Act (“BsUFA”).

 

 

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Written by Scot B. Pittman

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BsUFA authorizes FDA to collect user fees for the review of biosimilar biological product applications.  The current legislative authority for biosimilar user fees expires in September 2017, and FDA cannot continue to collect user fees without reauthorization.  Relatedly, on Monday, FDA announced that it will hold an upcoming public meeting to discuss proposals for reauthorization.  The proposals include enhancements to the existing biosimilars user fee program in four key areas: (i) review performance; (ii) meeting management; (iii) guidance development, and (iv) fee/program administration.

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Supreme Court
On September 9, 2016, Apotex Inc. filed a petition for a writ of certiorari in the Amgen Inc. v. Apotex Inc.[1] case decided by the Federal Circuit on July 5, 2016.  Apotex’s petition was placed on the Supreme Court’s docket on September 14, 2016 as No. 16-332.  Amgen’s response is due on October 14, 2016.

There are two issues raised in Apotex’s petition: (1) whether a biosimilar applicant must provide notice of commercial marketing when it complied with the patent dance; and (2) if notice of commercial marketing is required, whether notice can be effective prior to FDA approval of the biosimilar application.  The Federal Circuit held that notice of commercial marketing is mandatory and not effective until after the biosimilar application is approved.  Amgen, 2016 U.S. App. LEXIS 12353, at *36 (“We conclude that an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing begins, regardless of whether the applicant provided the (2)(A) notice of FDA review.”).

Apotex makes two arguments in its petition: (1) the notice of commercial marketing provision provided by the Biologics Price Competition and Innovation Act (“BPCIA”) is not mandatory, especially where the biosimilar applicant engaged in the patent dance; and (2) even if notice is required, it can be provided before a biosimilar application is approved.

Corn
On July 29, 2016, President Barack Obama signed S.764 into law. The law amends the Agricultural Marketing Act of 1946 to require that the U.S. Department of Agriculture (“USDA”) establish and oversee a national bioengineered food disclosure standard. Under the law, USDA has two years to promulgate regulations that establish the disclosure standard, as well as any related requirements and procedures that the Agency deems necessary.

Under the law, any disclosure regulations that USDA promulgates shall: (i) prohibit a food from being considered “bioengineered” solely because the animal from which it was derived consumed feed that was bioengineered; (ii) set the amounts of a bioengineered substance that need to be in a food for it to be considered “bioengineered”; (iii) establish a process by which other considerations may be given to whether a food is “bioengineered”; (iv) require that the bioengineered disclosure be a text, symbol, or electronic or digital link (e.g. a QR or Quick Response Code), with the disclosure option to be selected by the food manufacturer; (v) provide alternative reasonable disclosure options for food with small packaging; (vi) for “small food manufacturers,” provide at least one additional year for compliance with the disclosure regulations, as well as the additional option to disclose that the food contains bioengineered material through a phone number or internet website, (provided that they indicate that the number or URL provides access to additional information); and (vii) exclude food served in restaurants or “very small food manufacturers”—to be defined by USDA—from the disclosure requirements.

While the law should ultimately lead to more information on food labeling and enable consumers to make more informed choices about their food, it has also received significant criticism. For example, opponents of the law say that the definition of “bioengineered foods” is unduly narrow.

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Congress passed the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) to give the U.S. Food and Drug Administration (“FDA”) new authority to regulate the safety of marketed drugs. As part of this authority, FDA may require drug companies to propose and implement Risk Evaluation and Mitigation Strategy (“REMS”) for certain drugs whose risk- benefit profiles warrant safety measures beyond professional labeling. FDA may require REMS as part of the approval of a new drug or biologic (brand or generic), or for an approved product when new safety information arises. If FDA determines that a drug has been shown to be effective but is associated with an adverse drug experience, the FDA will require that the REMS have elements to assure safe use (“ETASU”). An example of an ETASU is that health care providers who prescribe the drug have particular training or experience or are specially certified.

The FDA, Federal Trade Commission, and generic drug manufacturers have raised concerns that branded drug manufacturers could be using REMS to impede generic competition. One concern is that branded companies may use REMS distribution restrictions to deny generic companies the drug samples they need to conduct necessary testing and otherwise meet the requirements for generic drug approval. Another concern is that branded drug firm may abuse situations where FDA approval of a generic drug is conditioned on the utilization of a single, shared ETASU by both the generic and branded companies. Essentially, the concern is that branded firms are impeding negotiations of a single, shared ETASU in order to delay generic entry.

To address these concerns, the Senate Judiciary Committee introduced Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016 on June 14, 2016. The bill—co- sponsored by Senators Grassley (R-IA), Klobuchar (D-MN), Leahy (D-VT), and Lee (R-UT)— permits a generic manufacturer to sue the branded manufacturer if: (1) the branded manufacturer fails to “provide sufficient quantities of [a drug sample] on commercially reasonable, market- based terms”; or (2) branded and generic manufacturers are unable to develop single, shared ETASU after 120 days of initiating a request to develop a shared ETASU. The relief contemplated in the bill is (1) a court order that the brand company provide the drug sample or the brand and generic develop single, shared ETASU or generic firm join a pre-existing ETASU; and (2) monetary award.

troll.jpgOnce again, legislation aimed at deterring abusive patent litigation is making headlines. The Patent Litigation Integrity Act of 2013 (S. 1612) was introduced by Senator Orrin Hatch, R-Utah, on October 30, 2013, and seeks to address patent troll litigation abuses by targeting “the economic incentives that fuel frivolous lawsuits.”

Patent troll litigation is often characterized by non-practicing entities, holding patents in a shell company with very few assets, who bring baseless claims, and seek nuisance settlements. The Bill seeks to address those concerning aspects of patent troll litigation in two ways: (1) by awarding fees to the prevailing party and (2) by requiring patent trolls to post a bond sufficient to cover the accused infringer’s fees.

Fees would no longer just be awarded to the prevailing party in exceptional cases at the court’s discretion. In the proposed Bill, the court would be required to award fees to the prevailing party, except if the court found that the nonprevailing party’s position was substantially justified or the award would be unjust. With this deterrent, the Bill hopes that patent trolls will think twice about bringing baseless claims and that defendants, knowing they will be awarded their fees if they prevail, won’t be as quick to take a nuisance settlement.
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[Update: After unanimously passing the Senate on November 18, 2013, H.R. 3204–the Drug Quality and Security Act–is set to become law after an expected signature from President Obama. President Obama signed into law on November 27, 2013.]

On November 12, 2013, the Senate voted to close debate on and advance a compounding pharmacy bill–H.R. 3204–aimed at tightening government oversight of pharmacy compounding and creating a national tracking system for prescription drugs. The 97-1 vote indicated overwhelming bipartisan support for the proposal, which passed the House in September. The lone dissenter, Sen. David Vitter, objected to a final Senate vote on the proposal because he wanted the Senate to first vote on a measure that he proposed to require lawmakers to disclose which of their aides are signing up for health insurance under the Affordable Care Act and which are remaining in the Federal Employee Benefit Program.

Originally introduced in the House by Rep. Fred Upton, H.R. 3204–the Drug Quality and Security Act–seeks to address two major concerns regarding the safety and quality of the U.S. drug supply. First, and in response to last year’s deadly meningitis outbreak, the Bill seeks to strengthen government oversight of compounding pharmacies. More specifically, Title I–the Compounding Quality Act–would amend the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) as to the regulation of compounding pharmacies, which have historically been regulated by state pharmacy boards. Under the proposal, pharmacies that perform traditional, small-scale compounding will continue to be regulated by state pharmacy boards. Additionally, drugs compounded by or under the direct supervision of a licensed pharmacist in a facility can elect to register as an outsourcing facility. In doing so, these drugs would be exempt from the FD&C Act’s labeling, new-drug, and proposed track-and-trace requirements if certain conditions were met, including: (1) proper registration of the facility; (2) no compounding using bulk drug substances; (3) compounding with ingredients that comply with applicable standards; (4) no compounding of drugs that have been withdrawn or removed due to lack of safety or efficacy; (5) no compounding of drugs that are essentially a copy of one or more approved drugs; (6) no compounding of drugs that have been identified as ones that present demonstrable difficulties for compounding; (7) no sale or transfer of the compounded drug by any entity other than the outsourcing facility; and (8) appropriate labeling.

The Bill also seeks to increase protection of the prescription-drug supply chain. More specifically, Title II–the Drug Supply Chain Security Act–will establish requirements to establish a track-and-trace system that will follow prescription drugs from manufactures to retail pharmacies. This national system should facilitate greater protection against counterfeiting, earlier detection of possible drug shortages, simpler recalls of defective drugs, and other drug supply-chain issues. While there will be certain waivers and exemptions, the proposal would require drugmakers to affix a product identifier on each package and case of product intended to be introduced in a transaction into commerce. Ten years after enactment, the Bill adds an electronic-tracing requirement. The Bill will require FDA to publish guidelines: (1) establishing standards for the interoperable exchange of transaction information, transaction history, and transaction statements; and (2) establishing the process by which companies may obtain waivers, exceptions, and/or exemptions to the product-identifier requirements. The national track-and-trace program will also preempt all state and local requirements regarding tracing drugs through the supply channels.
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pharmacy.jpgCompounding pharmacies are petitioning against a recent bill that would give FDA greater control over compounding manufacturers of sterile products. S.959, The Pharmaceutical Compounding Quality and Accountability Act, was unanimously passed by the Senate Health, Education, Labor and Pension Committee on May 22, 2013, and places compounding manufacturers that sell sterile products over state lines under FDA control.

The Bill, authored by Senator Tom Harkin, was a response to a deadly meningitis outbreak reported by FDA in October of 2012. The U.S. Centers for Disease Control and Prevention (“CDC”) traced the outbreak to fungal contamination in three lots of methylprednisolone acetate used for epidural steroid injections made by the New England Compounding Center (“NECC”). The CDC reported that the NECC meningitis outbreak has made 745 people sick and has caused 58 deaths in the United States. On May 24, 2013, another meningitis outbreak was announced. This recent outbreak was reportedly caused by Tennessee-based Main Street Family Pharmacy’s methylprednisolone acetate injections. The recent outbreak has sickened 24 people in Illinois, North Carolina, Florida, and Arkansas. These meningitis outbreaks have spurred the legislation that is being petitioned against.

Currently, individual States oversee their own compounding pharmacy operations. The potential shift from State to FDA control is worrisome to many pharmacists, doctors, and their patients. Specifically, there is concern that the FDA may ban compounded bio-identical hormones used to treat chemical imbalances.
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Obamabudget.jpgOver the past months, there has been a lot of speculation (see recent blogs here , here, and here) whether the White House’s proposed budget would cause a sequester situation for FDA, resulting in potential layoffs or program cuts, in an era of new user fees for generic drugs and biosimilar biological products. While initial reports and temporary budget fixes (called continuing resolutions) appeared to keep FDA’s user fees intact and available for use, FDA’s Commissioner, Margaret A. Hamburg, M.D., recently reported to members of a biotechnology trade association, the Massachusetts Biotechnology Council (“MassBio”), that it was not clear what would happen with user fees in the new federal budget.

Released on April 10, the White House’s proposed fiscal year 2014 budget is a mixed bag that has been called a “political document rather than a serious piece of legislation” with a “series of bargaining positions” that “would bleed pharma.” On the one hand, the plan would appear to confirm that FDA’s user fees would not be sequestered, given that it supported the $4.7 billion in total program budget requested by FDA, which included user fees that would help fund over 90 percent of the requested increases. On the other hand, the budget includes a myriad of proposals that would change the way the government pays for medical care and products. For example, Medicare (senior citizens’ drug coverage) Part D manufacturer discounts for branded drugs would be increased from 50% to 75% in 2015 (rather than 2020) and low-income individuals would be pushed more to generic drugs by increasing certain copayments for branded drugs and lowering certain copayments for generic drugs.

Many of the more controversial proposals were nestled in a document called “Reducing the Deficit in a Smart and Balanced Way”. Here, the White House proposes, among other things, several items to purportedly lower drug costs, including: 1) authorizing the Federal Trade Commission to stop companies from entering into certain “pay-for-delay” agreements (see below) and 2) beginning in 2014, to reduce biologic product exclusivity from 12 years to 7 years and prohibit additional periods of exclusivity for minor changes to product formulations. These two items could open up some unanticipated debate regarding the White House’s budget.
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With the $85 billion spending cuts now in effect, it is time for FDA and other agencies to adapt. The 2013 impact will be condensed into the next seven months because the federal fiscal year ends on October 1. While few details have been made available, FDA Commissioner Margaret A. Hamburg, M.D. said in an interview on Thursday that she did not anticipate FDA having to furlough workers and emphasized that the majority of the effects would not be felt in the short term. However, Hamburg estimated that the cuts will result in more than 2,000 fewer food safety inspections: “[C]learly we will be able to provide less of the oversight functions and we won’t be able to broaden our reach to new facilities either, so inevitably that increases risk.” FDA may renew efforts to implement a user fee program for the food industry to offset this hit.

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for dna.jpgOn January 28, The New York Times reported that biotechnology companies are actively lobbying state legislatures to limit access to biosimilar versions, i.e., “highly similar” versions of previously-approved, innovator biological products (“biologics”). According to the author, Andrew Pollack, Amgen and Genentech are proposing bills that would make it more difficult for pharmacists to substitute biosimilar versions for the innovator’s products, unless FDA determines that a particular biosimilar version is “interchangeable” with the innovator’s product.

For instance, the Virginia House of Delegates reportedly already passed such a bill last week by a 91-to-6 vote. Other bills in the works require patient consent for substitution, pharmacist notification of the patient’s physician if a switch is made, and for both the pharmacist and patient’s physician to maintain records of any such substitutions for years.

The Generic Pharmaceutical Association (“GPhA”) and insurers generally accept that biosimilar substitution for a biologic should follow similar methods as with drugs only if deemed interchangeable by FDA but find that many of the bills go further to discourage use of biosimilars. “All of these things are put in there for a chilling effect on these biosimilars,” commented Brynna M. Clark, Director of State Affairs for GPhA, adding that many of the limits “don’t sound too onerous but undermine confidence in these drugs and are burdensome.” GPhA and insurers would prefer that legislatures leave biosimilar regulation to FDA, which has been entrusted with using its regulatory prowess to determine the necessary requirements for biosimilars and “interchangeable” biosimilars, as well as when to waive those requirements based on what is know about a particular biosimilar product.
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