Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Jill Wechsler

Despite shortages in critical components and experienced staff, vaccine manufacturers anticipate significant boosts in output in the coming weeks for these innovative products. The companies with the first Emergency Use Authorizations (EUAs) for vaccines to combat the pandemic produced only 63.7 million doses as of Jan. 31, 2021, far less than the initial goal of 300 million doses, raising skepticism of even meeting the 200 million-dose goal for the end of March 2021. But in recent weeks, the prospects for greater vaccine output have brightened, and the entry of Johnson & Johnson into the market should help. To prevent future production delays of critical products, the Biden administration is examining supply chain vulnerabilities for pharmaceutical ingredients as part of a longer-range consideration of products important to public health.

Efforts to expand production of vaccines to combat COVID-19 have had to overcome a wide range of shortages in materials, qualified facilities, and experienced workers such as engineers and quality control managers. A particular problem is scarce supplies of the ionized lipid nanoparticles needed for the Pfizer-BioNTech and Moderna mRNA vaccines. Only a handful of companies previously produced very small amounts of lipids, most for clinical trials involving rare disease treatments. More contract manufacturers now are licensing the lipid technology, but production scale-up has been a slow process. In addition, finish/fill operations have emerged as serious bottlenecks due to shortages affecting key components for new and revised operating lines plus requirements for high levels of sterility.

 recent hearing before the House Energy & Commerce subcommittee on Oversight & Investigations,

 leading vaccine makers outlined efforts to enhance production and packaging processes. Pfizer Chief Business Officer John Young summarized company plans for boosting vaccine shipments from 5 million to 13 million doses per week by the middle of March. Similarly, Moderna President Stephen Hoge outlined efforts to deliver millions of doses by the end of March and other increases leading to a total of 700 million doses this year.

Johnson & Johnson now expects to provide 100 million doses of its single-dose adenovirus vaccine by the end of June 2021, starting with 20 million doses by late March, following FDA granting Emergency Use Authorization (EUA) for the product. Janssen Vice President Richard Nettles described for the House committee how the company had to assess nearly 100 potential production sites to find eight able to support its accelerated development timeline. Drug substance production takes about two months and is being done at Emergent BioSolutions in Maryland and at Janssen’s Netherlands plant and another facility in India, Nettles explained. And another five to six weeks are needed to produce, test and release the drug product, which is occurring at U. sites in Indiana, Michigan, and Pennsylvania, plus operations in Spain, Italy, India, and Africa.

Pfizer-BioNTech now projects 2021 global production to reach 2 billion doses, almost double early estimates. Some of that increase is due to FDA approval for extracting six doses per vial, as opposed to five doses originally approved. Pfizer CEO Albert Bourla provided further details on company production scale-up in conjunction with

 President Joe Biden’s visit to Pfizer’s Kalamazoo, MI manufacturing facility on Feb. 19, 2021

. Bourla cited plans to add new formulation suites and lipid production in Kalamazoo and at its research site in Groton, CT. Additional finish/fill lines have been established at its McPherson, KS site. This expansion, together with contracts with two additional US contract manufacturers and improved processes, will enable Pfizer to reduce the time needed to produce vial-ready product from 110 days to 60 days. Innovations involve doubling batch size to increase yield and utilizing more efficient lab test methods to reduce release times.

In addition, Pfizer’s vaccine will be easier to ship and store with FDA approval of higher temperatures – that is sub-zero (-15 to -25 oC), as opposed to the ultra-cold level initially authorized. That change is based on stability studies conducted over the past nine months and should facilitate distribution to pharmacies and smaller health facilities.

Moderna’s production gains arise from added efficiencies in creating batches of the drug substance at its facility in Norwood, MA and at the Portsmouth, NH plant operated by contract manufacturing partner, Lonza, Ltd. Moderna also is expanding its fill/finish process agreement with Catalent and looking to contract with another partner. And the company expects to speed up manufacturing runs with FDA approval of providing 15 doses per vial, filling up the empty space in vials that currently hold 10 doses.

The difficulties for manufacturers in securing critical ingredients for vaccine production, packaging, and delivery has prompted the Biden administration to assess the situation as part of a larger review of shortages related to components of critical industrial products. In an Executive Order issued Feb. 24, 2021, 

President Biden initiated a comprehensive review 

of supply chain risks for APIs, critical minerals, semi-conductors, and large-capacity batteries. The aim is to identify factors underlying shortages and supply interruptions of these products and steps the government can take to address relevant problems in the short term. Pharmaceutical products are considered particularly vulnerable in a pandemic or other global crisis due to the high proportion of offshore production of APIs.

To reduce such problems in the future, the White House plans to examine more broadly US supply chain issues related to products important for public health and biological preparedness, as well as for national defense, communications technology, food production, and the industrial base for energy, transportation, and communications sectors. Federal agencies will review goods and materials vulnerable to supply chain disruptions, locations of key manufacturing and production assets, the availability of alternative sources for critical goods, and issues arising from a failure to develop needed domestic capabilities. This initial review of supply chain vulnerabilities leaves off the more strident “Buy American” rhetoric of the Trump administration, but it opens the door to further initiatives to support more “on-shoring” of biopharmaceutical production.

Articles

To prevent future production delays of critical products, the Biden administration is examining supply chain vulnerabilities for pharmaceutical ingredients as part of a longer-range consideration of products important to public health. 

COVID-19 Vaccine Makers Overcome Challenges to Ramp Up Production

In a highly publicized challenge to unbalanced marketing of an opioid painkiller, FDA issued a public statement and press release, along with a sharp 

 rebuking AcelRx Pharmaceuticals for its glib and simplistic messaging on painkiller Dsuvia. The admonishment signals FDA’s intent to take strong action against misleading promotion of high-risk medicines, perhaps also seeking to deflect outside criticism of Acting Commissioner Janet Woodcock for supporting the approval of certain risky pain medicines when director of the Center for Drug Evaluation and Research (CDER).

FDA’s main objection in this case is that AcelRx’ s “tongue and done” headline highlights Dsuvia’s easy administration, while also minimizing product risks. FDA cites banner headlines with large type and illustrations touting a one-step administration process. At the same time, the message requires viewers to scroll through paragraphs of text to find limitations of use and 

Such skewed messages here are doubly troubling to FDA, as this pain medicine is subject to a risk evaluation and mitigation strategy (REMS) to restrict its use, and its label carries a boxed warning highlighting the need to avoid misuse through careful monitoring and administration.

The agency’s criticism of this unbalanced presentation of risk/benefit information reflects a common complaint of pharma promotions and follows a 2009 

 on the topic. This warning letter is the first compliance action taken by CDER’s Office of Prescription Drug Promotion (OPDP) this year and could be a signal of more actions of this sort to come. OPDP has been fairly quiet in recent years in challenging industry marketing activities, but this announcement aims to signal the agency’s “commitment to combat inappropriate opioid use” and its willingness to challenge violative marketing for high-risk products in general, and opioid therapies in particular.

OPDP also is responding to changes brought by the pandemic by doing more to challenge misleading or inaccurate messages related to treatments for COVID-19, according to a review of the 

. In outlining priorities and programs for this year, acting OPDP director Katie Gray also notes a continued focus on ensuring balanced communications on high-risk drugs.

FDA issued a public statement and press release, along with a sharp warning letter rebuking AcelRx Pharmaceuticals for its messaging on painkiller Dsuvia.

FDA Blasts Misleading Opioid Promotion

With two innovative vaccines beginning to provide protection against the coronavirus for Americans and people around the world, and more on the way, scientists and policy makers are looking more sharply at the lag in identifying and producing medicines to moderate early infections and to treat seriously ill patients. And the demand for effective therapies has escalated with the emergence of new COVID-19 variants.

Much of the blame for limited progress in this area lies with the lack of collaborative, centralized research programs able to identify and collect valid data on existing and new therapies. Instead, hundreds of researchers and clinicians have launched multiple trials of available drugs, most without adequate controls and size needed to yield useful evidence. Moreover, the focus on developing monoclonal antibodies (mAbs) that are delivered intravenously has created difficulties for patients and providers.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), noted in a recent 

that while some available therapies have been effective in treating some patients, there has been no “knock-out punch” against the virus. Administering mAbs, he explains, means a patient has to go to a hospital or infusion center, which are ill-suited for treating outpatients in early disease stages. What is needed, he said, is a “concerted effort” for developing effective combination antiviral agents that can suppress COVID-19 completely, as done for HIV and hepatitis C.

Moncef Slaoui, former co-director of Operation Warp Speed (OWS), similarly acknowledged the need for mAbs with formulations that permit subcutaneous or intramuscular injection to facilitate outpatient delivery to patients with mild infections. He lamented that the centralized approach for developing vaccines did not work for therapeutics, where multiple researchers have launched hundreds of small trials, most with no controls.

One sign of progress is FDA’s recent authorization of a mAb cocktail from Eli Lilly that features a notably shorter infusion timeframe than other similar treatments. FDA granted 

Emergency Use Authorization (EUA) for this combination of bamlanivimab and etesevimab

 with an infusion time of 16 minutes, instead of an hour. And ongoing tracking of testing for therapeutics to treat COVID-19 by 

 the release of data from late-stage studies on nearly 30 therapies, including 10 immune modulators in Phase III or IV trials plus studies on antimicrobials and antithrombotics. 

Several immune modulators are participating in the collaborative ACTIV-1 IM trial organized by the National Institutes of Health (NIH). More notable is the RECOVERY trial in the United Kingdom, which has yielded important clinical results on potential pandemic therapies, including a recent study showing that the rheumatoid arthritis treatment, Tocilizumab, from Roche can reduce deaths in hospitalized COVID-19 patients when combined with the steroid dexamethasone. Equally important is earlier RECOVERY findings that the much-touted malaria drug hydroxychloroquine was not beneficial.

But aside from a handful of such collaborative studies, most COVID-19 research on potential therapeutics has been sponsored by individual biopharma companies and academic research centers. Janet Woodcock, who has directed OWS therapeutic development this past year on leave from her position as director of the Center for Drug Evaluation and Research (CDER), reports that only 5% of the more than 400 clinical trials underway worldwide could be considered sufficiently “randomized and adequately powered” to achieve statistical significance. 

hosted by the Clinical Trials Transformation Initiative (CTTI), Woodcock, now FDA acting commissioner, lamented the waste and duplication created by a “plethora of small, single-center trials,” most without control arms and sufficient size and structure to yield results.  Moreover, the situation has created shortages in research supplies and in personnel, as well as competition for patients at medical centers, she added.

Former FDA Commissioner Rob Califf, now with Verily and Google Health, similarly reported that of thousands of interventional studies to test COVID-19 therapies listed on the ClinicalTrails.gov website, most have just a few sites and have been slow to enroll patients. And many trials continue to study questionable treatments, such as hydroxychloroquine and convalescent plasma.

on the accomplishments of its Pandemic Recovery and Preparedness Plan (PREPP) last year noted that there are no new FDA-approved therapies for COVID-19, despite nearly 3000 clinical trials on record through data from Clinicaltrials.gov and the World Health Organization as of November 2020. The report concludes by calling for broader use of adaptive trial designs and master protocols to avoid such waste and redundancy. 

At the CTTI conference, research experts reported on progress in expanding collaborative research programs in the United States, such as NIH’s ACTIV-3 and ACTIV-4 studies and the REMAP-CAP multi-center trial. A group of leading biopharma companies formed the COVID R&D Alliance last summer to collaborate in identifying and testing repurposed and new compounds through platform trials and data sharing. And the emergence of new virus variants is raising the need for more joint efforts, as FDA prepares new guidance to facilitate the testing and modification of vaccines, diagnostics, and therapeutics to combat new pathogens, with an eye to encouraging more productive clinical research methods. Such initiatives aim to address the critical problems that have delayed effective development of COVID-19 treatments so far and to build support for more coordinated centralized clinical testing programs before the next pandemic.

Scientists and policy makers are looking more sharply at the lag in identifying and producing medicines to moderate early infections and to treat seriously ill patients. 

Where Are the Therapeutics to Combat COVID-19?

The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates. Consumer representatives have pressed to name Joshua Sharfstein to the job, a step up from serving as FDA principal deputy commissioner during the Obama administration; research and patient organizations seek to retain Acting Commissioner Janet Woodcock as permanent head of the agency. The administration’s inaction so far has set up the current situation as an unofficial trial period for Woodcock to display her leadership ability and political savvy as pressures continue for resolving the coronavirus pandemic.

A main claim against Woodcock is that she didn’t do enough to keep dangerous opioid treatments off the market in her long stint as director of the Center for Drug Evaluation and Research (CDER) and that she too often champions industry interests. Several leading 

 back Sharfstein as best able to balance public health with industry regulation. At the same time, more than 

to the top job based on her deep understanding of how the complex and vital agency works after 37 years at FDA. Sharfstein, previously Maryland public health commissioner and now a dean at Johns Hopkins University, appears more of a reformer, which makes industry nervous but pleases many Democrats.

Other names have emerged as possible candidates to lead FDA, including previous agency officials Amy Abernathy and Luciana Borio. Former FDA Commissioner David Kessler dropped out of the running when he agreed to serve as scientific leader of the Biden administration’s pandemic countermeasures program, which will involve key FDA initiatives in new drug development, expanded manufacturing, and vaccine delivery.

One factor underlying the current debate is a mounting confrontation on Capitol Hill over confirmation of the administration’s choice to head the Department of Health and Human Services (HHS). The Senate appears headed for a contentious debate over the appointment of California Attorney General Xavier Becerra to lead the department. Republicans criticize Becerra for contributing to California’s failures in combatting the pandemic in California, which has led to lawsuits and strong pushback in that state. Conservatives also oppose his support for abortion rights, for “Medicare for All,” and for expanding Medicaid.

At the same time, Becerra has alienated the pharmaceutical industry by siding with hospitals in the debate over 340B drug discounts and championing a range of drug price control proposals. His background in public health and the greater urgency to address the pandemic is expected to focus his attention more on health care coverage and access issues, and less on overseeing biomedical research and regulatory policy.

Meanwhile, Woodcock is busy at FDA preparing policies to facilitate the speedy review and approval of revised vaccines and medical products to address rapidly spreading COVID-19 variants. FDA also is readying its analysis of the new COVID-19 vaccine from Johnson & Johnson in preparation for the upcoming advisory committee review hearing in two weeks, and more new coronavirus vaccines and therapies are moving through clinical testing. The use of Emergency Use Authorizations (EUAs) to permit patient access to these innovative treatments will face further scrutiny as the pandemic winds down.

At the same time, FDA is under continued pressure to meet timeframes for approving the many non-COVID medical products moving through the R&D pipeline and to address shortages in vital ingredients and medicines aggravated by the pandemic. A recent agency decision to put off approval of a controversial Alzheimer’s drug will have to be revisited. FDA also is in the midst of negotiating renewed user fees with industry, which have to be approved by Congress through legislation that regularly provides a vehicle for wide-ranging reforms and new FDA initiatives. Woodcock has long championed policies to modernize drug manufacturing and to create a more efficient and effective clinical research system in the United States, and these efforts have gained added impetus from pandemic pressures.

A main assignment for FDA’s new commissioner will be to restore the agency’s independence and reputation for relying on science in regulatory decisions in the wake of very public attacks on its authority by Trump administration leaders. These pressures on FDA, particularly in the last days of the former administration, have turned up the volume on calls for FDA to be an independent agency, separate from HHS. It is clear that FDA will remain in the spotlight for months to come, and strong, permanent leadership is needed sooner, rather than later.

The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates. 

New Leadership for FDA Entangled in Politics

In March 2020, FDA halted most field inspections of biopharmaceutical facilities and clinical research sites due to travel and contact restrictions imposed by the COVID-19 pandemic. Agency officials said they would rely more on the past compliance history of a production site, quality control documents requested from the manufacturer, and inspection reports and other information from other trusted regulatory authorities to determine whether an inspection was needed to approve a new or changed product from that facility. The agency also has weighed the viability of conducting virtual inspections, with limited success. More commonly, FDA has expanded product inspections in its labs or import control facilities to assure quality.

 This article was originally published online on Jan. 7, 2021.

The inspection hiatus did not delay most new product approvals for much of 2020, as many drugs came from facilities that had been recently inspected or had a sufficiently strong compliance record to support a regulatory decision. But now inspection issues are delaying more new product approvals. In December 2020, FDA postponed approval of an important new cholesterol therapy, inclisiran, from Novartis because of concerns about the European contract manufacturer producing the new product. FDA sent Novartis a Complete Response Letter (CRL) on Dec. 18, 2020, explaining that it could not approve the drug by its user fee action date due to “unresolved facility inspection-related conditions” that could not be overcome due to foreign travel restrictions (1).

FDA also delayed approval in November 2020 of a chimeric antigen receptor T cell (CAR-T) liso-cel therapy to treat adults with large B-cell lymphoma from Bristol Myers Squibb (BMS) when travel restrictions prevented an inspection of the contract manufacturer’s (Lonza) production facility in Texas (2). Also in November, Revance Therapeutics acknowledged it would not be able to market a new injectable anti-wrinkle skin treatment because FDA was unable to inspect the company’s California manufacturing facility on time (3). FDA similarly delayed the review of Spectrum’s neutropenia drug, Rolontis, which the company licensed from a South Korean firm that FDA was unable to inspect (4). And Alkermes said it received a CRL for its new treatment for schizophrenia and bipolar disorder when a remote records review done in place of a preapproval inspection found issues related to a tablet-coating process at its Ohio facility (5). Alkermes resubmitted its application in late December and now expects an approval decision by mid-2021.

Although agency officials indicated in July 2020 they might start conducting some critical domestic site visits, few occurred as infection rates accelerated again. FDA issued guidance in August addressing a range of questions related to the inspection situation to help manufacturers cope (6).

The agency further acknowledged the growing difficulties created by the inspection hiatus in guidance posted Dec. 21, 2020 to clarify how quickly (or slowly) it would act following a manufacturer’s response to a CRL when a facility assessment remains necessary before FDA can approve an original drug application or important supplement (7). The advisory states that reviews of resubmitted applications for products that require an inspection may take four or six months or more.

The December guidance notes the difficulties in conducting necessary facility assessments and acknowledges that it often is not feasible to rely on alternative tools, such as records requests or review of inspection reports from trusted foreign regulators, and that such strategies “can be as resource intensive as inspections” (7). Analysts note, moreover, that some FDA requests for GMP-related documents have been extensive, involving line listings, lab reports, and adverse event notices, requiring multiple data submissions that raise concerns about data security.

The agency’s distrust of alternative oversight methods applies particularly to production sites with past compliance problems, observed Don Ashley, director of Office of Compliance at the Center for Drug Evaluation and Research (CDER). He reported that the agency is doing more product sampling this past year, relative to site inspections, in weighing the need to issue warning letters or import alerts, at a December 2020 FDA enforcement conference sponsored by the Food & Drug Law Institute (FDLI).

Ashley further expressed skepticism about utilizing alternative oversight strategies for follow-up inspections of companies looking to remedy issues raised in earlier Official Action Indicated (OAI) citations. He noted that most follow-up inspections of such sites in prior years revealed that earlier problems had not been corrected, giving him “reason for pause” in relying closely on company reports on resolving serious issues.

An interesting point is that an FDA prior-approval inspection is not required to authorize an Emergency Use Authorization (EUA) for a drug or biologic. FDA officials emphasized that they were not cutting corners in moving quickly to approve EUAs for critical vaccines to counter COVID-19 based on accelerated clinical testing, and that companies had to submit full information on manufacturing processes and to establish quality control operations. But actual site inspections are not required until the manufacturer files a biologics licensing application for its vaccine, although enforcement officials may take other steps to ensure quality production.

In granting an EUA in November 2020 to Eli Lilly for a monoclonal antibody (bamlanivimab) to treat moderate COVID-19 infections on an outpatient basis, FDA directed Lilly to retain an independent third party to review batch records for discrepancies in drugs made at a New Jersey facility that had been cited for quality control issues at previous inspections (8).

1. Novartis, “Novartis receives complete response letter from U.S. FDA for inclisiran,” Press Release, Dec. 18, 2020.
2. BMS, “Bristol Myers Squibb Provides Regulatory Update on Lisocabtagene Maraleucel (liso-cel),” Press Release, Nov. 16, 2020.
3. Revance Therapeutics, “FDA Defers Approval of DaxibotulinumtoxinA for Injection in Glabellar Lines Due to COVID-19 Related Travel Restrictions Impacting Manufacturing Site Inspection,” Press Release, Nov. 25, 2020.
4. Spectrum Pharmaceuticals, “Spectrum Pharmaceuticals Announces that the FDA is Deferring its Action on the BLA for ROLONTIS (eflapegrastim),” Press Release, Oct. 26, 2020.
5. Alkermes, “Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review,” Press Release, Nov. 17, 2020.
6. FDA, 

Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers, Guidance for Industry 

Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry

Jill Wechsler is BioPharm International’s Washington editor, jillwechsler7@gmail.com.


Vol. 45, No. 2
February 2021
Pages: 14-15

When referring to this article, please cite it as J. Wechsler, "FDA Inspecti34 on Shutdown Delays Drug Approvals," 

FDA puts applications on hold as the agency limits alternative oversight methods. 

FDA Inspection Shutdown Increasingly Delays Approvals

Recent manufacturer price hikes have kept the spotlight on drug costs and reimbursement, generating calls for legislation and regulations to curb outlays on medicines. Economic hardships aggravated by the pandemic, as seen in high unemployment and closed schools, support initiatives likely to reduce medical bills, particularly pharmaceutical prices that appear arbitrary and unjustified. Now with Democrats controlling Congress and the White House, expectations are high that policy makers will revise certain coverage and payment policies.

One popular proposal is to impose penalties on drug companies that raise prices faster than the rate of inflation. And there’s a renewed clamor for authorizing the federal government to negotiate drug prices on behalf of individuals enrolled in Medicare Part D. But opposition from Republicans and pharma companies may make it hard to move forward quickly in that area.

Less controversial is the push for greater transparency in medical prices, as seen in 

 requiring hospitals and insurers to publish list prices, including negotiated rates for prescription drugs. So far, the courts have rejected challenges from hospitals, and the cry for public access to cost information is strong. 

Analysis from the Institute for Clinical and Economic Review (ICER) 

and other organizations furthers such efforts, as seen in ICER’s recent “naughty list” of 10 top pharmaceutical “price gougers” that raised prices on widely used drugs in 2019 without conducting any “meaningful” clinical research to support added uses or safety information [see 

New legislation and rule making, however, will await further assessment of multiple regulations and policies approved in the last days and weeks of the Trump administration. It’s common for a new administration to impose a 60-day delay on adopting rules, guidance documents, and agency actions not yet in effect to permit further scrutiny of new and often obscure proposals.

the “most favored nation” interim final rule 

issued in November 2020 that links federal reimbursement for certain drugs covered by Medicare to lower prices paid by European nations. This policy is controversial, and manufacturers have challenged it in court. International drug price comparisons regularly support such changes, as seen in a 

that documents higher drug prices in the United States compared to 32 industrial countries.  But quick uptake of the complex proposal is unlikely.

The Biden administration has postponed implementation of 

another rule that revises policies governing manufacturer rebates and discounts to Medicare drug plans

. Pharma companies support this curb on discounts to pharmacy benefit managers (PBMs), but PBMs strongly oppose the change and have challenged it in court. The Centers for Medicare and Medicaid Services (CMS) published a final rule implementing the program in November, but then delayed it for several months. Legal and political issues may put this change on the back burner, but the Federal Trade Commission (FTC) may become more active investigating whether rebates for favorable insurance coverage limit industry competition.

There also will be close scrutiny of another “midnight” 

Trump proposal that narrows coverage requirements for most Medicare Part D “protected” drug classes. 

 The aim is to test the impact of dropping the requirement that plans cover at least two drugs in five (of six) protected drug classes and also of permitting Part D formularies to cover only one, instead of two, drugs per class. Manufacturers and patient advocates strongly support Medicare-protected drug classes as key to ensuring adequate coverage of more costly, hi-tech medicines for cancer, transplants, AIDS, and mental conditions. HIV treatments remain protected under the plan, but reimbursement could decline for anticonvulsants, immunosuppressants, antidepressants, antipsychotics, and antineoplastics. It’s a contentious issue, but some kind of pilot test program could move forward.

Broad support for more value-based purchasing in health care may help advance recent CMS efforts to update the Medicaid drug rebate rule. A 

revises how Medicaid rebates are calculated to reduce the impact of “best price” on the broader market.  CMS may move to extend the current one-year implementation timeframe to permit further scrutiny by Congress and the new administration.

Pharma companies are concerned, though, that changes in Medicaid best price could affect rate calculations for hospitals under the federal 340B drug discount program. An escalating dispute between manufacturers and CMS over revised rules and policies governing this program has generated lawsuits and eroded industry participation. At issue is whether 

manufacturers must offer discounted 340B prices

 to pharmacies that dispense drugs for certain hospitals, a practice that 

 claim greatly expands the volume of discounts beyond its original intent. Look for the “340B wars” to be an early test for the new leadership at HHS.

With Democrats controlling Congress and the White House, expectations are high that policy makers will revise certain coverage and payment policies. 