FDA Lawyers Blog

On May 10, FDA denied a Citizen Petition submitted on behalf of Endo Pharmaceuticals Inc. ("Endo"). The Petition requested that FDA: (1) determine that Opana® ER (oxymorphone hydrochloride) Extended-Release Tablets ("OP") were discontinued for safety reasons, (2) refuse to approve any pending abbreviated new drug application ("ANDA") for a generic version of OP, and (3) suspend and withdraw the approval of any ANDA referencing OP as the reference listed drug. By statute, if a drug was withdrawn from sale for reasons of safety or effectiveness, FDA must refuse to approve any pending ANDA and suspend or withdraw any approved ANDA referencing the drug.

FDA initially approved the New Drug Application ("NDA") for OP held by Endo on June 22, 2006. The approved label advised that the product should be swallowed whole and warned against crushing, chewing, snorting, or injecting the dissolved product to prevent uncontrolled delivery, overdose, and death. FDA approved two ANDAs referencing OP in December 2010. Generic versions of the product entered the market in July 2011 and January 2013, respectively.

Written by Shelly Fujikawa. Ph.D

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Written by Brian J. Malkin

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FDA approved an NDA for a reformulated version of OP, also called Opana® ER (oxymorphone hydrochloride) Extended-Release Tablets ("OPR"), held by Endo on December 9, 2011. FDA found that OPR could still "dose dump" and approved a label for ORP that was virtually identical to the approved label for OP. Endo ceased shipping OP on May 31, 2012 and submitted the present petition in August 2012 which was subsequently supplemented with preliminary postmarketing data and analysis concerning the abuse of OP, generic versions of OP, and OPR.

The fight over whether versions of the emergency contraceptives Plan B and Plan B One-Step (collectively "Plan B") should be available without a prescription to all women continued yesterday. Lawyers for FDA appeared before Judge Edward Korman of the Eastern District of New York urging him to stay his April 4 Order requiring the Agency to lift age restrictions on access to emergency contraceptives by May 10. FDA has appealed that ruling to the Second Circuit. The Agency has yet to implement the court's directive, but in late April it approved a supplemental new drug application ("sNDA") that lowers the age at which women can obtain these drugs without a prescription from 17 to 15. Judge Korman expressed skepticism as to the timing of the approval and criticized the Agency for not following his order. A ruling on the stay is expected by the end of this week.

FDA's actions have received mixed reviews. Last week, President Barack Obama reiterated his support of FDA's and the Department of Health and Human Services' ("DHHS's") determination that the age-restriction should be fifteen. He said that he was "very comfortable with the decisions they've made." Others have been more critical. Nancy Northup, President and CEO of the Center for Reproductive Rights, speaking after the Department of Justice's appeal to the Second Circuit said, "We are deeply disappointed that just days after President Obama proclaimed his commitment to women's reproductive rights, his administration has decided once again to deprive women of their right to obtain emergency contraception without unjustified and burdensome restrictions."

Written by Scot B. Pittman

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The approval of Plan B has a long history. Originally approved in 1999 for prescription-only use, Plan B became the United States' first emergency contraceptive. In February 2001, sixty-six organizations filed a Citizen Petition with FDA urging the Agency to switch Plan B, as well as any other emergency contraceptives, from a prescription-only drug to an over-the-counter ("OTC") drug and remove all age and point-of-sale restrictions. Despite repeated claims that it would address the outstanding petition, the Agency waited over five years to rule--denying the Petition in June 2006. FDA claimed that the petitioners had failed to provide sufficient data or information to meet the statutory and regulatory requirements of an OTC switch to any age group.

Last week, the U.S. Patent and Trademark Office ("USPTO") instituted its first inter partes review of a design patent, U.S. Patent No. D617,465 ("the '465 Patent") assigned to Luv N' Care, Ltd. Petitioners, Munchkin, Inc. and Toys "R" Us, Inc., successfully persuaded the Patent Trial and Appeal Board that "there is a reasonable likelihood that Petitioners would prevail with respect to the sole claim of the '465 Patent."

The claim of the '465 Patent recites "the ornamental design for a drinking cup, as shown and described." The '465 Patent includes five figures of a drinking cup having a vessel, collar, and spout. The Petitioners alleged that the claim of the '465 Patent was obvious over U.S. Published Patent Application No. 2007/0221604 published September 27, 2007 ("Hakim '604") and, separately, obvious over U.S. Patent No. 6,994,225 issued February 7, 2006 ("Hakim '225"). The Petitioners also presented numerous combinations of references to assert that the claim of the '465 Patent was obvious. These additional obviousness arguments were grouped into nine categories according to the primary reference being asserted.

Written by Shelly Fujikawa. Ph.D

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As an initial matter, the Board addressed the effective filing date of the claim of the '465 Patent since several asserted references were intervening prior art, in particular Hakim '604 and Hakim '225. The '465 Patent issued from U.S. Application Serial No. 29/292,909, which was filed on October 31, 2007, as a continuation of U.S. Application Serial No. 10/536,106 ("the '106 Application"), which is the national stage of PCT Patent Application PCT/US03/24400 filed August 5, 2003. The Board concluded that the claims were not entitled to the benefit of the filing date of the '106 Application, because the '106 Application did not have sufficient disclosure to demonstrate that the inventor possessed the claimed subject matter at the time of filing the '106 Application. In particular, the drawings of the '106 Application do not show the same design as the drawing of the '465 Patent.

This week The Venture Café in Cambridge, Massachusetts hosts Life Sciences Week with a special focus on life science research in the Greater Boston area. Featured life science research speakers include Akrivis (ADAPT™ technology, which allows cancer detection much earlier by increasing the sensitivity of early biomarker detection and enabling the medical imaging of millimeter-sized cancer tumors), Human Metabolome Technologies (metabolome profiling for tumor metabolism, biomarker discovery and production optimization), Advirna (powerful and innovative tools to regulate activity of genes inside living cells), Heartbt Foundation (newly-developing non-profit seeking to boost translational research by bridging medical, professionals, big pharma, researchers, NGOs, the general public, and others), Extend Biosciences (startup biotech company with a platform technology that enables the development of long-acting peptide based drugs), Anchor Therapeutics (pre-clinical stage drug discovery company advancing Pepducin Technology, a novel approach towards allosteric modulators of G-protein coupled receptors), Lab Central (soon-to-open facility to house up to 65 scientists, in 20 individual lab stations and 9 private lab suites in the heart of Kendall Square), and Cellanyx (biomarker-based diagnostic biopsy test to determine oncogenic and metastatic potential for prostate tumors). The Venture Café will also host a Roundtable of Life Sciences Entrepreneurship in Massachusetts, featuring Peter Abair of the Massachusetts Biotechnology Council ("MassBio"), Pamela Norton from the Mass Life Sciences Center, and Peter Parker of Lab Central.

Written by Brian J. Malkin

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During Life Sciences Week, FLH Partner Brian J. Malkin will host Office Hours from 3-5pm EST along with several other service providers in the healthcare field. Mr. Malkin's Office Hours description reads:

Chat with Brian J. Malkin, Partner at Frommer Lawrence & Haug LLP. Brian specializes in FDA-regulated products, in particular pharmaceutical, biotechnology products and biosimilars. Discuss intellectual property, pathways for FDA approval, as well as life cycle management and due diligence investigations. Brian frequently speaks on a variety of IP- and FDA-oriented topics, and is editor of the FDA Lawyers Blog.

This blog is a second part to a blog here, describing Annual Conference for the Food and Drug Law Institute ("FDLI") held on April 23 and 24, 2013, its in Washington, D.C.

On the first day, FLH Partner Brian J. Malkin spoke on a panel discussing the priorities for the Center for Biologics Evaluation and Research ("CBER"). The two key CBER presentations came from Diane Maloney, J.D.., Associate Director for Policy, and Mary Malarkey, Director, Office of Compliance and Biologics Quality. The panel also included Michael S. Reilly, Executive Director, Alliance for Safe Biologic Medicines, and Mark S. Robbins, Ph.D., Vice President, Clinical Regulatory Affairs, DiaMedica USA, Inc. and was moderated by Scott Cunningham, Partner, Covington & Burling LLP. A key issue raised by panel was the status of biosimilars. Reilly, for example, was concerned that there may be misinformation about biosimilars, especially because there is no public information concerning biosimilars applications being considered in the United States. Malkin asked when FDA planned to issue additional guidance, because FDA's guidance has so far been very general and concerns pre-investigational or pre-biosimilars application stages, not the key issues of interchangeability and naming that have been debated. Maloney explained that CBER and the Center for Drug Evaluation and Research ("CDER") have been discussing strategy, even though there still have been no filed biosimilar applications, and would issue additional guidances. At the same time, Malkin and others acknowledged that at the state level, legislators have been passing bills that specifically prohibit substitution of biosimilars for their referenced counterpart, unless FDA deems the biosimilar "interchangeable" and naming issues and more persist.

Written by Brian J. Malkin

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A question was raised about a pending Citizen Petition that includes an argument that it was a taking for biosimilar applicants to file applications referencing biologic products before the passage of the Biologics Price Competition and Innovation Act ("BPCIA") (March 23, 2010). In this Petition, Abbott argued that before this date, when biologics license applications ("BLAs") were submitted, their sponsors had "reasonable, investment-backed expectations that the trade secrets in their applications would not be used to approve competing products." Abbott asserts, therefore, that FDA's use of trade secrets in these BLAs to support biosimilar approvals "would constitute a taking under the Fifth Amendment to the U.S. Constitution. FDA should not implement the BPCIA in any manner that would raise constitutional issue." While most panel members declined to respond, Malkin hazarded a guess that based on comments FDA has made (see for example here) and in the context of FDA's Citizen Petition response for a similar issue concerning 505(b)(2) new drug applications (where a similar takings argument has been made), FDA wanted to decide that there was no "taking," but FDA has not answered the petition in part because no biosimilar application has been filed to date.

On April 23 and 24, 2013, the Food and Drug Law Institute ("FDLI") held its Annual Conference in Washington, D.C. As expected, FDLI's Conference featured the FDA Commissioner, Margaret A. Hamburg, M.D., presentations from leaders from all of FDA's Centers and the Chief Counsel, Elizabeth Dickinson, and leaders from industry, academia, and the legal bar. Unlike previous years, however, there were far fewer FDA attendees due to budget cuts, and FDA seemed more reluctant to use the Conference as a platform for announcing new policy or initiatives.

Hamburg kicked off the Conference with her recognition that FDA's budget was cut, along with other government agencies, noting that it would make times tight but that there are no planned furloughs. Hamburg said that this fiscal year, FDA lost about $209 million-$126 million in budget authority and $83 million in user fees. FDA will continue to collect user fees, but FDA cannot use them this fiscal year due to the sequesteration issue. Hamburg said that the reduced budget would mean reductions in programs but did not specify which ones. Yet, at the same time, Hamburg emphasized that FDA has been busy implementing its new regulatory authorities, including the new Center for Tobacco Products and authorities in the Food and Drug Administration Safety and Innovation Act ("FDASIA").

Written by Brian J. Malkin

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Hamburg stressed that it has become more and more apparent that its regulated industries need to build quality in their products. She highlighted that quality issues have caused two out of three drug shortages, and FDA has uncovered "shockingly unsafe drugs" at compounding pharmacies. Over the past several months, Hamburg explained, FDA has been inspecting compounding pharmacies and has found unidentified black particles in what were supposed to be sterile injectable products, rust and mold in sterile rooms, and products being processed with bare hands. At the same time, FDA has encountered increased resistance during its inspections, resulting in at least two cases needing administrative warrants. Hamburg said that FDA believes there should be a distinction between traditional and nontraditional compounding--traditional is individualized to patient; nontraditional is sterile product prepared out of state compounded and anticipated without a prescription. For nontraditional compounding, FDA has asked Congress for more clear FDA authority to monitor and examine records in the "patchwork" of compounding rules.

The U.S. Food and Drug Administration ("FDA") announced last Tuesday that it would not approve any generic versions of the original formulation of the prescription narcotic painkiller OxyContin® ("original Oxycontin®"). OxyContin® is a brand name for oxycodone hydrochloride, an opiate-based pain medication. Original Oxycontin® has been marketed by Purdue Pharma since 1995 and is notorious for its user misuse and abuse.

OxyContin® contains a large amount of oxycodone because it is designed to release the pain-relieving drug over an extended 12-hour period. However, original Oxycontin® can easily be crushed and then snorted or injected (or even sprinkled on food) to produce a rapid and intense euphoric high. The abuse of original OxyContin® in this manner can lead to addiction and dependence and has reportedly earned the product the nickname "hillbilly heroin." Its accessibility has magnified abuse rates; FDA reports that half a million people over age twelve began using original OxyContin® for non-medicinal purposes in 2008 alone. According to the Center for Disease Control, the death toll from prescription painkiller overdoses tripled in the first decade of the 21st century, and such overdoses "now kill more Americans than heroin and cocaine combined."

Written by Rachael P. McClure

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In addition to a patent for original OxyContin, which expired on Tuesday, Purdue Pharma also owns a patent for a reformulated, abuse-deterring version ("reformulated Oxycontin®"). This newer version was designed to resist being crushed and to form a gel that is difficult to inject when dissolved. Notably, FDA approved an updated label for this product last week, specifying the tablets' crush-resistant properties and warning of the fatal risks of misuse. (The label information is available here.) Purdue withdrew original OxyContin® from the market when its new version was approved in 2010 but retained the trade name.

Next week, FLH Partner Brian J. Malkin will speak at Center for Biologics Evaluation and Research ("CBER") Panel at FDLI's Annual Meeting held in Washington, D.C. on April 23-24. The CBER Panel will be held on the first day of the Conference, Tuesday, April 23, from 2-3:30 p.m. FDLI has posted the key two presentations by CBER Representatives Diane Maloney, Esq., Associate Director for Policy, and Mary Malarkey, Director, Office of Compliance and Biologics Quality. The panel will be moderated by Scott Cunningham, Partner, Covington & Burling LLP, and also includes Michael S. Reilly, Executive Director, Alliance for Safe Biologic Medicines, and Mark S. Robbins, Ph.D., Vice President, Clinical Regulatory Affairs, DiaMedica USA, Inc.

As demonstrated by the presentations already posted by Maloney and Malarkey, the panel has a lot of ground to cover, and we as panel members have been providing feedback for additional topics to address as time permits. All of us hope for a lively discussion following the initial presentations and hope to see you there!

Written by Brian J. Malkin

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FDLI's Annual Conference is the largest (750+ attendees expected) and longest running conference for the FDA-regulated industry, which now includes tobacco products. FDLI's program brings together experts from the Federal Government, industry, private sector bar, consulting organizations, and academia in one place to discuss legal, regulatory, policy, and economic issues falling in FDA's vast authority. FDA Commissioner, Margaret A. Hamburg, M.D., will provide the Keynote Address the first day, with other plenary sessions featuring FDA's top regulatory and compliance officials, breakouts for all of FDA's centers and a sessions featuring compliance and liability issues. The next day features top cases in food and drug law, concurrent breakouts in emerging issues, an address from FDA's Chief Counsel, Elizabeth Dickinson, and plenary sessions in interagency dynamics and the role of the media in food and drug law, regulation, and policy.

The European Medicines Agency ("EMA") has released their report giving detailed information regarding numbers of patients, sites and inspections with respect to pivotal clinical trials submitted in marketing authorization applications ("MAA") between January 2005 and December 2011.

As we noted in a previous blog there has been an increase in concern amongst regulators and the public about how well clinical trials are conducted from an ethical and scientific/organizational standpoint, and especially with regard to good clinical practice ("GCP") compliance. An applicant has to provide information in every MAA regarding the location, conduct and ethical standards applied in respect of the clinical trials conducted in third countries.

Written by Howard E. Rosenberg, Ph.D.

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The report relates mainly to new applications (485), line extensions (95), and variations where new clinical trial information was provided (97). Generic applications are included as part of the new applications, but they generally do not add much to the number of patients, because these applications are mainly based on small bioequivalence trials, but they do provide information on the locations where these trials were conducted.

On April 15, the U.S. Supreme Court heard oral arguments in Assoc. for Molecular Pathology v. Myriad Genetics, Inc. et al., the famous case concerning the patent-eligibility of human gene patents. At issue is the validity of Myriad's patents on the human genes, BRCA1 and BRCA2, but ruling would surely cover the patent eligibility of all animal and plant genes and impact various biotechnology industries. Additional details may be found in previous blogs, for instance here and here.

The Justices appeared skeptical of Myriad's argument that isolated DNA is patent-eligible subject matter. Isolated DNA is DNA that is cut from a chromosome, resulting in an "isolated" piece of DNA that has the same nucleotide sequence as the naturally-occurring genomic DNA.

Written by Dan Constantinescu, Ph.D.

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The Justices compared Myriad's isolated DNA to the discovery of plants with medicinal properties. Justice Breyer commented that it was long-standing patent law that while particular applications of such a plant can be patented, the plant cannot be. If someone discovers a medicinal plant "he gets a patent on the process, on the use of the thing, but not the thing itself." Justice Sotomayor expressed her understanding that to obtain a patent "you had to take something and add to what nature does" and wondered, "how do you add to nature when all you are doing is copying its sequence?"

Over 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.

Written by Brian J. Malkin

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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.

On April 7, Simeon Bennett from Bloomberg reported that individual members of the European Union are attempting to control the cost of medical care by containing the reimbursement of drugs intended for smaller patient populations, generally called orphan drugs. In Europe, orphan drugs are defined as a medicine to treat no more than 5 in 10,000 inhabitants. Many of these drugs undergo a centralized approval process via the European Medicines Agency (see related blog resource page here.) In practice, however, these drugs may only reach the market when each member state decides that its national health system will reimburse for the drug. For example, 35 orphan drugs reached the market in Belgium, 44 in the Netherlands, and 28 in Sweden in 2008. 35 such drugs reached the market in France and 23 in Italy in 2007.

According to Yann Le Cam, CEO of Eurodis, a French patient advocacy group for patients with rare diseases, "The price of orphan medicinal products is under much more debate. We have seen countries which were providing good access to orphan medicinal products now questioning the continuation of reimbursement."

Written by Brian J. Malkin

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Some examples provided in the Bloomberg report included the Netherlands demanding price reductions for certain therapies such as Sanofi's Myozyme® (alglucosidase alfa), an enzyme replacement therapy for patients with Pompe disease, which costs 700,000 euros ($909,000). As we previously reported from MassBio's Annual Meeting, Myozyme® was the largest research and development effort in the history of Genzyme, which was later acquired by Sanofi, and the result of a concerned father of two children with Pompe's disease pushing the promising therapy along to help it reach the public. Another example mentioned in the report included Ireland recommending against the government paying for Vertex Pharmaceuticals, Inc.'s Kalydeco® (ivacaftor) for cystic fibrosis until the company significantly reduced the price for the drug product. Yet another example was the rejection by the United Kingdom ("UK") to expand use of Alexion Pharmaceuticals, Inc.'s drug Soliris® (eculizumab) for two blood disorders, despite the recommendation for this use by an advisory panel. Instead, the government referred the matter to its National Institute for Health and Care Excellence, which we recently blogged on here, as an instrument to encourage value-based medicine in the UK.

On April 1, FDA provided a combined response to three citizen petitions concerning the regulation of over-the-counter ("OTC") nicotine replacement therapy ("NRT") drug products. The petitions were submitted by the Commissioner of Health, New York State Department of Health (Docket No. FDA-2008-P-0116), the Director, Legal Resource Center for Tobacco Regulation, Litigation & Advocacy, University of Maryland Francis King Carey School of Law on behalf of the Association for the Treatment of Tobacco Use and Dependence ("ATTUD") and the Society for Research on Nicotine and Tobacco ("SRNT") (FDA Docket No. FDA-2008-P-0116), and four not-for-profit organizations, the American Cancer Society Cancer Action Network, the American Lung Association, the Campaign for Tobacco-Free Kids, and the American Legacy Foundation (FDA Docket No. FDA-2010-P-0454). For additional background on this topic generally, please see an earlier blog that we posted here about a NRT workshop that FDA held in October 2010 addressing the topics in these petitions.

Written by Brian J. Malkin

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The petitioners asked FDA to consider modifying the labeling of OTC NRTs, certain policy changes, and allowing greater access to the products. While the requests varied, a common theme was that the petitioners wanted consumers to have greater access to NRTs in smaller packages that would permit more flexible use of the products, other than the typical up-to-12-weeks smoking cessation program scenario contemplated by the clinical studies that supported the use of these products. For instance, some of the petitioners suggested that the labeling should include additional risk/benefit information concerning NRTs versus continued cigarette (or other tobacco product) use, including possible concomitant use of cigarettes and NRTs, as well as longer-term NRT use to reduce and perhaps ultimately eliminate an individual's cigarette use. The not-for-profit petitioners wanted FDA to make the development of NRTs a priority within FDA, including certain collaborations with manufacturers of NRTs, such as the development of appropriate trial designs, and to transfer evaluation of NRTs from FDA's drug division for addiction drug products to its division for oncology drug products.

For some time now, there have been strident calls for the publishing of all clinical trial data. The pressure has arisen due to revelations that companies may have hidden crucial clinical data that might have shown that the drug being tested was not as efficacious or even as safe as they appeared from quoted trial results (see, for instance, a previous blog here). The campaign group AllTrials has brought together several people and groups (including for example David Tovey, editor The Cochrane Library; Ben Goldacre (book Bad Pharma); Carl Heneghan, Centre for Evidence-Based Medicine, University of Oxford) because, as they put it:

Around half of all clinical trials have not been published; some trials have not even been registered. If action is not taken urgently, information on what was done and what was found in trials could be lost forever, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated unnecessarily.

Key publications like the British Medical Journal and research bodies such as the Medical Research Council and the Wellcome Trust agree, the trust encouraging its grant recipients to release their trial data.

Written by Howard E. Rosenberg, Ph.D.

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The European Medicines Agency ("EMA") has been looking at this for some time, with the same aim in mind and is trying to develop a workable policy to enable the data to be published. Indeed it is thought that in the next few weeks, major players in the United Kingdom's medical community will meet to try and take things further in a more practical manner.

The United Kingdom's ("UK's") method of controlling the prices its Department of Health pays for innovative medicines has been, up until now, the Pharmaceutical Price Regulation Scheme ("PPRS"). The PPRS has been a voluntary scheme run over many years between the Department of Health and the branded pharmaceutical industry represented by the Association of the British Pharmaceutical Industry ("ABPI"). Its objective was to deliver the provision of safe and effective medicines at reasonable prices to the National Health Service ("NHS") while promoting innovation, the rapid uptake of new clinically and cost effective medicines, and in a sustainable manner.

Over recent years, the National Institute for Health and Care Excellence ("NICE") has been taking on a more visible and key role. Its job has been to improve outcomes for people using the NHS by producing evidence-based guidance by way of advice to healthcare professionals and to develop quality standards and measures for those providing health care services and also providing information to practitioners and managers in both health and social care.

Written by Howard E. Rosenberg, Ph.D.

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The UK Government's response to the Health Select Committee report of 2012-2013 on NICE was to re-establish NICE as a new statutory body giving it a key position in the healthcare system. It gives NICE the role of deciding the value-based pricing of medicines. Thus, value-based pricing will replace the current PPRS, when it expires in January 2014.