Drug Safety. Progress and Controversies

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This begs the question — on whom does the burden of proof lie? The regulator or the company? After the fiasco surrounding diabetes drug pioglitazone last year — banned and then put back — this order is welcome. It clearly states that if two or more countries ban a drug for reasons of either safety or efficacy the regulator will review the drug in India. Since the two regulators do not co-ordinate their actions and often take opposing views, this caused a good deal of controversy. The current order gives direction but still does not answer the main question.

I urge readers to humour me and read this sample. My eyes crossed by the time I reached the end — a side-effect for which I demand compensation. Try making sense of it. I am too busy trying to see straight again. Tags: cdsco , clinical trials , ranjit roy chaudhury. Like Like. The problem is that no one is India does a Quality check on the document that they have written.

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What to Know About Dsuvia, the Controversial New Opioid the FDA Just Approved

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In its justification for this proposal, the state has emphasized not only the budgetary strain of rising prescription drug prices but also concern over federal efforts to relax approval standards at the Food and Drug Administration FDA , which approves new drugs. On the other hand, the Trump administration proposal would require the demonstration states to opt out of the current drug rebate program entirely and use formularies instead. The latter approach is significantly flawed, as there would be no guarantee that these states could maintain the same level of savings that they currently receive under the rebates, raising the possibility that state Medicaid drug spending could actually increase under the proposal.

Medicaid Drug Rebate Program State Medicaid payment for prescription drugs is complex, and includes the Medicaid Drug Rebate Program. Most states have supplemental rebate agreements in addition to this federal requirement. Furthermore, drug manufacturers who refuse to agree to additional rebates may have their drugs referred to the state Medicaid Drug Utilization Review Board, which will conduct a value assessment and recommend a target rebate amount.

If the manufacturers do not agree to sufficient rebates after the value assessment, the state Medicaid program can subject all of their drugs to penalties. New York is currently on track to trigger the cap in for the first time, and the state has begun the process of reviewing high-priced drugs and negotiating additional rebates. The widespread pharmaceutical industry practice of annually hiking prices on existing drugs far in excess of the rate of inflation has increasingly become a major source of concern for patients and policymakers.

Recently, a panel of the 4th U. Circuit Court of Appeals ruled that this law violates the U.

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For example, the Illinois House of Representatives recently passed a similar price gouging bill in April States have explored several other types of reforms in addition to the three categories detailed above. Most recently, the governor of Vermont signed legislation to legalize the importation of prescription drugs from Canada, making Vermont the first state to enact such a law. Importantly, although ESMO-MCBS is focused solely on the level of clinical benefit and, as such, diverges from the HTA system, validation of the tool by comparisons with outcomes of national HTA decision-making showed a high degree of concordance [ 13 , 15 ].

The FDA and Prescription Drugs: Current Controversies in Context - HarvardX on edX

There are other similar initiatives that aim to evaluate the value of cancer treatment regimens and share the basic elements of clinical benefit, toxicity and quality of evidence [ 16 , 17 ]. The recently updated American Society of Clinical Oncology value framework assesses the value of cancer therapies based on clinical benefit, side effects, and improvements in patient symptoms or quality of life in the context of costs [ 16 ]. Whether these initiatives could speed up patient access to reimbursed drugs still has to be shown; however, the new framework that is being developed between the European public authorities, the governments and the health councils should help to speed up European pricing reimbursements.

In the period when a therapy has gained marketing authorization and is no longer available to patients through clinical trials, but has not yet been granted approval or reimbursement, compassionate use programmes CUPs and named patient programmes NPPs can bridge this gap, enabling much-needed therapies to reach patients prior to approval or launch [ 19 , 20 ].

Expanded access systems provide patients who have a disease, for which there is no satisfactory authorized therapy or who cannot be entered into a clinical trial, with access to treatments that may ultimately provide benefit, but for which formal approval may arrive too late.

In USA, the Food and Drug Administration has allowed patient access to investigational drugs under certain circumstances since In the EU, countries have their own national regulations regarding access to unlicensed medication, but NPPs allow access in the period between submissions to health authorities, centralized EMA approval and market availability in an individual country. During the period between successful Phase III trial data, approval and reimbursement, patients are not always able to access new medicines that could significantly increase their survival or improve their quality of life.

As the length of this period differs between countries, patient access to new treatments becomes staggered.

Progress and controversies: Radiation therapy for invasive breast cancer

However, delays to novel oncology drugs occur throughout European countries. Herein, we describe the experience with nintedanib in combination with docetaxel, which was first approved in the EU in for the treatment of patients with non-small cell lung cancer NSCLC of adenocarcinoma histology after first-line chemotherapy. Most patients with advanced NSCLC treated with standard first-line therapies will experience relapse and disease progression [ 24 ], and until recently there had only been limited second-line therapies available.

Treatment of patients with advanced lung adenocarcinoma after the failure of first-line chemotherapy has been a significant unmet need, particularly in patients with poor prognosis and early-progressing tumours, highlighting the clear medical need for effective second-line therapies. Although progress in treatment options has been made for patients with actionable biomarkers, such as epidermal growth factor receptor EGFR mutations, anaplastic lymphoma kinase ALK translocations, or programmed death-ligand 1 PD-L1 overexpression, patients without known biomarkers still have fewer treatment options.

Nintedanib is an example of a new therapy in oncology that is addressing this high unmet need. In the global, Phase III, LUME-Lung 1 clinical trial, nintedanib in combination with docetaxel demonstrated a significant improvement in the key secondary endpoint of overall survival OS versus docetaxel and placebo in previously treated patients with adenocarcinoma histology median OS The 1-year survival rate was Time to progression or time since completion of therapy has been used in other trials to characterize early-progressing or refractory lung cancer patient populations [ 26—29 ].

What to Know About Dsuvia, the Controversial New Opioid the FDA Just Approved

Time since initial chemotherapy is a significant prognostic factor, with lower median OS in patients with shorter times elapsed between first- and second-line treatments [ 30 ]. Patients who do not respond to first-line chemotherapy have worse prognosis and have historically not fared well with subsequent treatment [ 32 ]. However, in an analysis that was not prespecified, non-responders to first-line chemotherapy—i. In this exploratory analysis, nintedanib and docetaxel improved OS HR 0.


These poor-prognosis patients represent a population with a very high unmet medical need. On the whole, the LUME-Lung 1 trial demonstrated that nintedanib in combination with docetaxel is an effective treatment for patients with adenocarcinoma NSCLC who have progressed after first-line therapy, particularly in patients with early progression to first-line therapy, who are known to have a worse prognosis. Number of patients with adenocarcinoma NSCLC projected to be treated yearly with nintedanib in five European countries [ 34—39 ]. NSCLC, non-small cell lung cancer.

Number of patients enrolled in compassionate-use or named-patient programmes of nintedanib in Europe up to February Data on file, Boehringer Ingelheim. Regulatory approval applications for nintedanib in combination with docetaxel have been submitted to regulatory bodies across the world and approval has been gained in a number of countries, including in the EU, Australia, Chile, Ecuador, India, Israel, Macau, Mexico, Norway, Paraguay, Russia, Serbia and Singapore.

The approval process is ongoing in other countries and, as a result, there is unequal patient access to nintedanib across the globe. Furthermore, in Europe, nintedanib plus docetaxel is currently reimbursed in Austria, Belgium, Croatia, Denmark on a named-patient basis , Germany, Greece, Luxembourg, The Netherlands, Spain, Slovakia, Slovenia, Sweden and UK [ 40 ], including Scotland, where the high unmet medical need and significant and meaningful OS benefit of nintedanib have been acknowledged.

The reimbursement processes are ongoing in several countries, including Ireland, Italy, Finland, Portugal and Poland.

JCDR - Drug market, banned drugs, bannable drugs, drug toxicity, controversial drugs.

Regulatory approval is essentially the first, and not the final stage, of the journey from a successful Phase III trial to patient access to a new therapy, and there are still many steps to take before it can be made readily available to patients across different countries. Although nintedanib in combination with docetaxel has satisfied the obligation of meeting a medical need, as noted by successfully receiving EMA regulatory approval, and was recommended in several European HTA evaluations, e.

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Drug Safety. Progress and Controversies Drug Safety. Progress and Controversies
Drug Safety. Progress and Controversies Drug Safety. Progress and Controversies
Drug Safety. Progress and Controversies Drug Safety. Progress and Controversies
Drug Safety. Progress and Controversies Drug Safety. Progress and Controversies
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