Jackie Syrop

The FDA has granted breakthrough therapy designation status to Genentech’s rituximab (Rituxan) for pemphigus vulgaris (PV), a rare, serious, and life-threatening autoimmune disease with limited treatment options.

 is intended to expedite the development and review of medications with early evidence of potential clinical benefit in serious diseases and to help ensure that patients get access to these medications as soon as possible. Patients diagnosed with PV are currently being enrolled for a phase 3 trial of rituximab.

Rituximab is currently approved for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis. 

The breakthrough status came following a review of data from a Roche-supported randomized trial conducted in France that evaluated rituximab plus oral corticosteroid treatment compared with corticosteroid as a first-line treatment in patients with moderate to severe pemphigus. (Roche markets rituximab outside the United States and Japan.) The study, which was published in 

, showed that Rituxan may provide substantial improvement in disease remission rates and successful tapering and/or cessation of corticosteroid therapy.

Meanwhile, there’s been progress with developing a biosimilar for rituximab. The European Medicines Agency (EMA) is expected to soon grant approval for Celltrion’s rituximab biosimilar (Truxima). The EMA’s Committee for Medicinal Product for Human Use 

 on December 16, 2016, that it had recommended granting marketing approval for rituximab biosimilar.  European oncologists expect the arrival of a rituximab biosimilar to slash costs and expand patient access to the expensive oncology treatment. Europe would be the first big market for rituximab biosimilars because a US approval of biosimilar rituximab is probably farther in the future. 

The rituximab biosimilar has already penetrated the Asian market—it was approved in 2016 in South Korea, covering all indications of the reference drug. In the United States, Celltrion is 

 with Teva, which will commercialize the biosimilar if approved here.  

Articles

Rituxan Given Breakthrough Therapy Designation for Pemphigus Vulgaris

 Roche’s humanized monoclonal antibody ocrelizumab (Ocrevus) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). Ocrelizumab is the first drug approved for PPMS, which is characterized by steadily worsening function from the onset of symptoms, often without early relapses or remissions.

About 15% of MS patients have PPMS. Ocrelizumab, which 

 CD20-positive B cells, is administered via intravenous infusion twice yearly after 2 initial 300 mg doses, a regimen that may be viewed as more convenient for patients. Most of the approved MS drugs are either 

 to earn more than $4 billion annually by 2022 and to be a “major market disrupter.” Roche said it was pricing the drug at an annual cost of $65,000 (that price does not account for rebates and discounts), which represents a 20% discount to the average price of other MS medications, the company noted. Roche intends to launch the drug in the US market in 2 weeks. It is currently under review by the European Medicines Agency.

The FDA granted ocrelizumab breakthrough therapy designation, priority review, and fast track designation. The 2 phase 3 studies of the drug involved 1656 participants treated for 96 weeks, which showed the drug significantly increased the length of time during which patients did not show signs of disease progression—relapse, confirmed disability progression, or new or enlarging lesions seen on MRI&mdash;compared with interferon beta-1a (Rebif). Ocrelizumab reduced the annual 

 by 50% compared with interferon beta-1a over 2 years. In a third phase 3 trial in patients with PPMS, which involved 732 participants and lasted at least 120 weeks, ocrelizumab performed better than placebo and could reduce signs of the disease, including the spread of MS lesions. The main results of all 3 trials were published in 

Ocrelizumab can cause serious infusion-related reactions. The most common side effects of ocrelizumab seen in clinical trials of patients with relapsing-remitting MS were upper respiratory tract infection; for patients with PPMS, the most common reactions were upper respiratory tract infection, skin infection, and lower respiratory tract infection. Ocrelizumab is not recommended for use in patients with hepatitis B infection.

New Drug Approved for MS, First With PPMS Indication

 by the FDA for the treatment of adults with moderate to severe eczema (atopic dermatitis, AD), which affects 7 to 8 million adults in the United States. Dupilumab is a monoclonal antibody that binds to the interleukin-4 receptor alpha subunit (IL-4Ra) that causes inflammation, inhibiting the inflammatory response that is involved in the development of atopic dermatitis. It is now a first-in-class immunotherapy for moderate to severe atopic dermatitis.

Administered as an injection under the skin, dupilumab is intended for patients whose eczema is not adequately controlled by topical therapies, or for those for in whom topical therapies are not advisable. The antibody can be used with or without topical corticosteroids.

Sanofi, which developed dupilumab in collaboration with Regeneron, 

 social media to spread the word on the new drug and bring atopic dermatitis patients together, working with patient groups and physician thought leaders to better understand eczema and highlight dupilumab as a treatment option. Sanofi has stated that its top goal is that dupilumab gets to the right patient—the patient whose disease is not controlled with a topical steroid. “If your disease could be controlled with a topical steroid, why would you use this drug?” Sanofi Genzyme CEO David Meeker asked. “That’s not the right patient for this drug, and that to me is almost as bad as the person who badly needs it not getting it.” The company also wants to educate payers about atopic dermatitis, so they really understand the disease and the quality-of-life issues faced by patients.

Data from 3 placebo-controlled clinical trials showed dupilumab to be safe and effective. The trials involved 2119 adult with moderate to severe AD that was not adequately controlled by topical medications. Study participants who received dupilumab achieved greater response (clear or almost clear skin) and experienced itch reduction after 16 weeks of treatment, according to the FDA. Results from an ongoing phase 3 study of dupilumab, recently presented 

 of the American Academy of Asthma, Allergy, and Immunology (AAAAI) in Atlanta, Georgia, showed that the drug can reduce signs and symptoms of moderate-to-severe AD, and improve skin lesions and pruritus among AD patients without any major safety issues.

Dupilumab can cause side effects such as serious allergic reactions and eye problems including conjunctivitis (pink eye) and inflammation of the cornea. The most common side effects include injection site reactions, cold sores in the mouth or on the lips, and eye and eyelid inflammation, including redness, swelling, and itching.

Classified as a breakthrough therapy, the drug was granted a priority review by the FDA. Sanofi said the drug will have a list price of $37,000 per year. While the price is more expensive than topical medicines and steroids currently used to treat atopic dermatitis, it is 

 than other injectable antibody drugs for serious skin conditions such as psoriasis. Financial analysts forecast annual sales for dupilumab exceeding $4 billion by 2022.

Sanofi indicated that it has “pivotal data” on Dupixent for an asthma indication that it expects to submit to regulators for that new use in the fourth quarter of 2017. The drug is also in phase 3 trials for nasal polyposis and is being studied in food allergies and eosinophilic esophagitis.

Dupilumab, a Biologic Treatment for Eczema, Approved by FDA 

The National Health Service (NHS) could begin to use its reimbursement system to incentivize hospital physicians to prescribe less expensive biosimilar medicines, according to NHS regional pharmacy procurement specialist Maggie Dolan, 

 at a recent Medicines for Europe biosimilars conference in London.

The attendees at the conference heard that it is not concerns about the science of biosimilars that is holding back their adoption, but a lack of incentives for switching from reference biologics to their less-expensive alternatives.

Dolan said that in England the NHS is having trouble finding ways to share the savings generated by biosimilars among “purchasers” of healthcare and “providers,” the 2 elements of the NHS system. So-called gainshare agreements, in which savings generated by biosimilars are equally shared between the group purchasing the service (Clinical Commissioning Group, CCG) and the hospital providing it, have shown promise but in some cases the CCGs and hospitals have not been able to agree on gainshare agreements. The areas where there is no gainshare agreement are the areas where biosimilars are not being used, Dolan explained.

An example of successful uptake of biosimilars was discussed: University Hospital Southampton NHS Foundation Trust, where use of the infliximab biosimilar for infliximab (Remicade) for its gastroenterologic indications has cut almost a million pounds from the hospital’s annual budget. Southampton hospital achieved this goal by coordinating between patient groups, the manufacturer, and commissioners.

NHS authorities may choose to try and use the reimbursement system to force physicians to use biosimilars in hospitals that are not prescribing biosimilars, Dolan said. In the near future, drugs will be reimbursed at the price of the biosimilar, so using the branded drug would cause hospitals to accumulate large amounts of debt. “I think we are not very far away from seeing examples of just that kind of pressure being put on doctors,” she said. Hospitals are under intense pressure to balance their books. She said she believes the difficult fiscal situation facing NHS will mean less “carrot” and more “stick,” not necessarily overnight but over the next year as funding arrangements are reviewed across the country. She added that adoption of biosimilar rituximab may be affected by NHS’ decision to steer clear of a national gainshare agreement. NHS has decided to give a refund to hospitals that achieve target usage goals under the country’s Commissioning for Quality and Innovation national goals.

The “stick” approach to encouraging biosimilar adoption is being used in Denmark, according to Steinar Madsen medical director of the Norwegian Medicines Agency, who also spoke at the conference. Madsen said Danish authorities have made Denmark a leader in biosimilar use by threatening doctors with cuts to staffing and services if they don’t use biosimilars. Nearly all hospitals in Denmark use biosimilars, he said. Once the biosimilar to adalimumab becomes available, possibly next year, AbbVie’s Humira will “disappear” from the Danish market, predicted Peter Jorgensen, director of the Danish generics and biosimilars industry body.

In the United States, the idea of incentivizing physicians to prescribe biosimilars may be of interest, especially with a new administration 

 healthcare costs. CMS, for example, could potentially put pressure on prescribers for millions of American patients covered through Medicare and Medicaid to more quickly adopt cheaper biosimilars as more are approved in the coming years.

NHS May Use More "Stick" Than "Carrot" to Ensure Prescribing of Cheaper Biosimilars 

 with key stakeholders on the future of biosimilars examined the expected impact of President Trump’s policies on the future of the biosimilar industry, how changes in regulation will affect the number of biosimilars approved, and what impact these changes will have on ensuring that biosimilars are safe and accessible for patients who need them. The Washington, DC, briefing on March 15, 2017, included Rep. Michael Burgess, MD, R-Texas, and chairman of the House Energy and Commerce Committee; David Fox, partner in the law firm of Hogan Lovells; Len Lichtenfeld, MD, deputy chief medical officer of the American Cancer Society; and Jim Van Lieshout, vice president of Market Access and Pharmacy Strategy at Apobiologix.

Rep. Burgess, a physician, has been in Congress long enough to have 

 2 previous iterations of the negotiations over the FDA user fee acts (in 2007 and 2012). Burgess’s description of his past experiences with the user fee negotiation process suggest there was “drama” and turbulence prior to each reauthorization, but he said that despite the friction and disagreements in those instances, the bills were signed, the work was done ahead of schedule, and the act was reauthorized for the next 5 years. Burgess noted that if there’s anything he can take away from his tenure on the Energy and Commerce Committee, it’s that members of Congress can occasionally put disagreements aside and do the right thing for the American people. For the Biosimilar User Fee Act (BsUFA) II to be renewed, Congress will again have to come to an agreement and sign off on it before the end of September 2017 when the current act expires. Uncertainty and friction is once again high in the Congress as a result of the proposed repeal-replacement of the Affordable Care Act (ACA) by the Trump administration, and the hiring freeze will complicate the FDA’s promise to increase staffing of the agency’s biosimilar review team. Rep. Burgess said Congress must aim for a July timeframe to sign off on the user fee act agreement because of FDA hiring practices and notifications.  

Looking to the future, Rep. Burgess said he hoped the Biologics Price Competition and Innovation Act (BPCIA) will become more efficient in the next 5 years of BsUFA II, assuming it is renewed. He said the FDA was responsible for bringing about efficiency, however, not the Congress. “The user fee agreements are stuck between the agency and the industry, and the subcommittee’s role is to oversee and ratify that process if it’s found acceptable,” he said. “We can’t have members of Congress deciding which biosimilars get approved and brought to the market,” no matter how much frustration there is between representatives of the FDA and industry.

Burgess stressed that if biosimilars are going to make a difference, there must be more approvals. The FDA and industry can expect Congress to look for significant increase in biosimilar approvals on the next “BsUFA report card,” he said, and stressed that biosimilars are needed so more patients can be treated for less money, a goal that he will kept in mind in his Committee work.

Policy Briefing Calls for More Efficient Biosimilar Approval Process 

A lawsuit was filed in federal court in New Jersey in which 4 individual plaintiffs and the Type 1 Diabetes Defense Foundation are 

 pharmacy benefit managers (PBMs) CVS, Express Scripts, and OptumRx, in addition to insulin makers Sanofi-Aventis, Novo Nordisk, and Eli Lilly, accusing them of colluding on prices of insulin.

On January 30, 2017, the first class-action lawsuit against insulin makers was 

 in federal court in Massachusetts alleging that the same 3 pharmaceutical companies engaged in an organized scheme to drive up their insulin prices at the expense of patients who needed insulin to live. The list prices of insulin have risen steadily, often in concert, despite competition among the 3 companies marketing insulin. Humalog, launched 2 decades ago at a price of $21 per vial, has increased to $255 per vial.

 filed in New Jersey on March 17, 2017, targets the same 3 insulin makers as the first lawsuit, and adds the PBMs CVS, Express Scripts, and UnitedHealth’s OptumRx to the lawsuit, claiming they were part of the alleged price-fixing scheme.

The 69-count class action suit alleges violations of the Employee Retirement Income Security Act (ERISA), federal antitrust and racketeering statutes, and the laws of all 50 states and the District of Columbia, and alleges that the drug makers significantly 

 on insulins, raising them in lockstep with one another and sharing additional revenues with the PBMs through rebates. The individuals filing the lawsuit receive health benefits through employer-sponsored health plans governed by ERISA, insurance plans purchased through the Affordable Care Act marketplaces, and Medicare Part D prescription drug plans.

“The skyrocketing cost of insulin cannot be explained away with typical drug company rationalizations for high costs,” the lawsuit states, adding that the increased list prices are the result of a scheme and enterprise among the 3 major manufacturers of insulin and the 3 largest PBMs that together control 80% of the benefit management industry, covering about 180 million people. The PBMs are alleged to have used their role as gatekeepers between health insurance plans and drug companies to steer plans towards certain drugs, including insulin treatments used by people with diabetes. The drug companies are alleged to then ratchet up the retail prices on those drugs and share the excess profits with PBMs through a rebate system the lawsuit calls a “massive slush fund,” a scheme that caused rapid and lockstep price increases of more than 150% in their insulin treatments.

 the allegations were without merit and built on a false premise. He countered that PBMs play no role in determining drug prices and said that CVS passes along more than 90% of the price discounts. Novo Nordisk disagrees with the lawsuit’s allegations and denied them, as did spokesmen for Express Scripts and Sanofi, which plan to defend themselves vigorously. OptumRx and Lilly have not yet responded to the lawsuit.

Attorneys from Critchley, Kinum & Denoia, LLC, in Roseland, NJ, and Keller Rohrback, LLP, in Seattle, are representing the plaintiffs in the case. The Type 1 Diabetes Defense Foundation is a nonprofit group that supports patients with type 1 diabetes.         

New Lawsuit Concerning Insulin Price-Fixing Filed in Federal Court

Amgen has filed for approval from the European Union’s European Medicines Agency (EMA) for ABP 980, its biosimilar of the breast cancer treatment trastuzumab (Roche’s Herceptin), according to a 

 by Amgen’s executive vice president and chief financial officer David Meline at the Cowen and Company 37th Annual Health Care Conference on March 8, 2017. The report also suggests that Amgen is likely to file for its trastuzumab biosimilar’s approval in the United States, but the timing for that event is uncertain.

A biosimilar for trastuzumab has not yet been approved by the EMA or the FDA. The EMA’s 

indicates that the agency is currently assessing 3 trastuzumab biosimilars, with Mylan/Biocon’s trastuzumab being the first under consideration for approval in 2017. Asia is already marketing a trastuzumab biosimilar and a recent court decision in New Delhi, India, allowed the marketing of Mylan/Biocon’s biosimilar of trastuzumab in that country.  

Launch of a biosimilar of trastuzumab in Europe is 

 before a similar approval in the United States, but indications are growing stronger that Mylan’s trastuzumab biosimilar may be approved in September 2017 based on the recent announcement that Mylan entered a global 

 with Genentech and Hoffman-La Roche on a patent for trastuzumab. The agreement will provide Mylan with global licenses for its trastuzumab biosimilar, which allows Mylan and partner Biocon to commercialize the drug around the world with the exception of Japan, Brazil, and Mexico. The agreement also ensures that the US market will see the first biosimilar to trastuzumab, once Mylan’s biologics license application—filed in collaboration with Biocon&mdash;is approved by the FDA.

The Biosimilar User Fee Act for trastuzumab is September 3, 2017.

Amgen Files for EU Approval of Its Herceptin Biosimilar for Breast Cancer

 of the Energy and Commerce Committee on the FDA’s Generic Drug User Fee (GDUFA) and Biosimilar User Fee (BsUFA) programs, stakeholders in industry and government regulatory agencies in the biosimilar and generic drug space agreed that both programs should be reauthorized before they expire at the end of September because of their importance in accelerating the review and approval of generic and biosimilar drugs. Both user fee programs authorize the FDA to collect fees from drug manufacturers to fund timely reviews and approvals of new generics and biosimilars. The recently unveiled fiscal year 

 calls for doubling FDA user fees to ensure that pharma “pay for their share” in a tightened budgetary environment. The drug and device industries had recently completed user fee agreements with the FDA, having agreed upon appropriate amounts of industry fees to support needed FDA improvements.

Witnesses at the hearing included Janet Woodcock, MD, director of the Center for Drug Evaluation and Research (CDER); Juliana Reed, immediate past president of the Biosimilars Forum; Bruce A. Leicher, president of the Biosimilars Council; Kay Holcombe, senior vice president of Science Policy, Biotechnology Industry Organization; and David Gaugh, senior vice president of Sciences and Regulatory Sciences of the Association for Accessible Medicines (formerly GPhA).

While the focus of the hearing was on the role and importance of user fees, members of the congressional committee brought up 

 ranging from rising US drug prices, President Donald J.Trump’s executive order requiring the elimination of 2 federal regulations for each new regulation enacted, and the proposed government hiring freeze and its effect on the drug approval process. An important theme of the hearing was timeliness, with many questions concerning how the FDA plans to decrease review times and increase first-cycle generic approvals. Only 9% of generic drugs are approved in the first review cycle, even after the 2012 authorization of GDUFA. New pharmaceuticals, by contrast, are primarily approved in the first review cycle, and there have only been four biosimilars approved to date.

Bruce Leicher, who is also vice president and general counsel of Momenta, testified that if renewed, BsUFA II promises the release of new guidances, more industry/agency meetings, better resource planning, and new hires at FDA for biosimilar drug reviews. Leicher noted that during BsUFA II and GDUFA II negotiations last year, the industry had called for more FDA staff to encourage quicker reviews and a more reliable meeting schedule, and more transparency on how user fees were being spent by the FDA. These elements are all part of the renewed BsUFA and GDUFA programs awaiting reapproval, and are key to improving communication between the FDA and the biosimilar sponsors so that sponsors get necessary developmental information early and can make any corrections before filing for approval.

BsUFA II, it was noted, will adopt the Prescription Drug User Fee Act’s program review model, which establishes communication timelines and opportunities to discuss any developmental issues that can potentially prevent approval of the biosimilar application.

At several points in the hearing, speakers brought up their concerns about achieving the goals of BsUFA II should an FDA hiring freeze come to pass. The FDA has already experienced challenges hiring staff over the last 5 to 6 years, which is affecting review times. The hiring freeze will likely cause issues in recruiting additional staff to review biosimilars, Woodcock emphasized. These hiring problems will affect the approval of more cost-effective drugs for Americans.

Congressional Hearing on FDA User Fees Tackles Issues Affecting Biosimilar Approvals

 for fiscal year 2018 presented by President Trump calls for huge disruptions in government-funded medical and scientific research, the extent of which go well beyond what was expected for federal health-related agencies that usually receive broad support from both Republicans and Democrats. The cuts to the National Institutes of Health (NIH) would fund the agency at a 

—NIH would see its budget cut by approximately 20% (nearly $6 billion) and the Department of Health and Human Services, or HHS, would be cut by $15.1 billion, slashing spending by NIH on agencies including the FDA, CMS, and Indian Health Service.

Trump’s budget blueprint, “America First: A Budget Blueprint to Make American Great Again,” calls for a major NIH reorganization to focus on “highest priority research” but fails to explain all the changes involved in reorganizing it, except for abolishing 1 program dedicated to building partnerships between health research institutions in the United States and other countries, and consolidating the Agency for Healthcare Research and Quality into NIH. The cuts to HHS, NIH, and other health agencies comes on the heels of a pledge made during Trump’s first 

 on February 28, 2017, to help fight and stop more diseases.

The budget document also states that FDA user fees will rise as pharma and biopharma should “pay for their share” in a constrained budget environment, calling for FDA medical product user fees to nearly double to “over $2 billion in 2018, approximately $1 billion over the 2017 annualized continuing resolution level.” 

 the Regulatory Affairs Professionals Society (RAPS), the administration is “presumably looking to renegotiate the user fee programs, which expire in September 2017, forcing companies to fork over an additional $600 million.” The drug and device industries had, in fact, recently completed user fee agreements negotiations with FDA, agreeing upon an appropriate amount of industry fees to support needed FDA improvements.

Researchers and medical experts are alarmed about the potentially disastrous effects a $6 billion budget cut to NIH would have on biomedical and other research. Investment in research and development has been widely regarded since World War II as critical to national prosperity and security. Scientific and medical research in the United States depends heavily on grants from federal agencies that would face dramatic budget cuts. NIH uses only approximately 10% of its $30 billion budget for NIH’s own in-house studies; more than 80% goes to 300,000 outside researchers. “President Donald Trump’s fiscal year 2018 spending plan erases years’ worth of bipartisan support for NIH, and the American biomedical research enterprise, which has long been the global leader for biomedical innovation,” 

 Benjamin Corb, of the American Society for Biochemistry and Molecular Biology, in an interview with 

. “Cuts this deep threaten American’s ability to remain a leader.”

UsAgainstAlzheimer’s chairman George Vradenburg said the cuts to NIH and medical research threaten to undo years of gains made in the fight against Alzheimer’s disease. He pointed out that the most direct path to healthcare cost savings is investing in research to achieve treatments and cures. The group reminded Trump that Alzheimer’s researchers have stated that the minimum level of annual funding to achieve the national goal of stopping Alzheimer’s by 2025 is $2 billion a year at NIH.

The budget eliminates $403 million in funding to train health professionals and nurses, calling the program ineffective. The budget 

 for the CDC beyond the creation of a $500 million block grant fund to help states respond to their specific public health challenges, but the source of the funds is not clear—whether this would be new funding or a reallocation.

Mention is also made of unspecified investment in mental health activities such as suicide prevention and a $500 million increase in substance abuse services funding aimed at addressing the opioid addiction epidemic.

The 2018 budget must be negotiated and approved by Congress.

Trump Administration Budget Blueprint Comes With Major Cuts to Health and Science

The FDA is responsible for oversight of all drugs, biologics, biosimilars, and medical devices marketed in the United States, but it is also dedicated to advancing public health. This includes an obligation to advance the development of safe and effective medical products for the greatest number of patients. Many patients need to take very expensive life-saving biologics but cannot afford access to them—a problem whose solution could lie with the development and marketing of lower-priced biosimilars that can be interchangeable with approved biologics. Despite promises made by the FDA to improve the agency’s transparency by making more regulatory decisions and analyses available to the public, there has not been enough progress, according to a recent article by Joshua Sharfstein, MD, of Johns Hopkins Bloomberg School of Public Health in Baltimore, and Michael Stebbins, PhD, of the Laura and John Arnold Foundation in Houston, in the journal 

The value of increased FDA transparency is gaining greater recognition because the European Medicines Agency (EMA), Europe’s counterpart to the FDA, has adopted policies to release large amounts of scientific information and analysis about regulated products, write Sharfstein and Stebbins. Several pharma and device companies now release data files in partnership with academic centers to allow independent analysis. FDA researchers have also shown that companies often fail to disclose the agency’s reasons for not approving product applications, and the authors believe that disclosing this information would help patients, physicians, and researchers, who could learn from such failures in drug development.

The FDA typically does not offer details about how many biosimilars are under review or comment on recent Complete Response Letters (CRLs), which explain why products cannot be approved. The FDA could, for example, propose a rule allowing at least portions of CRLs to be released by the FDA and for the agency to disclose biosimilar application numbers if it wished to. Jim Miller, JD, MPH, of the Department of Health Policy and Management at Johns Hopkins Bloomberg School of Public Health, said in an 

 that concerns about releasing trade secrets are overstated, because rules governing the FDA have a narrow definition of what constitutes trade secrets.

Miller and other researchers from Johns Hopkins, Yale, and Harvard Medical and Law Schools recently created “

,” which will be published later this year. The report makes 18 recommendations in 5 key areas, all of which can be implemented by the FDA without additional Congressional action. The report calls on the FDA to:

Disclose more information about key milestones of the application process

Disclose more of its own analyses and decision making

Disclose more about the application and review processes for generic drugs and biosimilars

Correct misleading information in the market

Further disclose data from research studies.

“The agency might consider adopting a standard based on whether the information has the potential to cause significant confusion in the medical community and among patients about the safety or efficacy of a medical product for approved or unapproved uses,” the report notes. FDA should retain the authority to release information under circumstances vital to the public health, it concludes.