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| Using this information, we determined that the time it takes to bring innovative, high-risk devices to patients in the United States is similar to or shorter than that in the top four European markets (see figureComparison of Time to Market in Premarket Approval and Reimbursement Processes.). The public (CMS) process in the United States takes approximately as long as those in Italy and Britain, approximately half as long as that in France, and less than a third as long as that in Germany. The difference in time to market access is even greater when it comes to private insurers (covering the majority of the U.S. population), which often make reimbursement decisions within a few months after FDA approval.
By the time Kefauver began his investigation into the pharmaceutical industry in the late 1950s, the escalating expense of lifesaving prescription drugs was illustrating that the free-market approach to medical innovation had costs as well as benefits. From the development of insulin in the 1920s, through the “wonder drug” revolutions of sulfa drugs, steroids, antibiotics, tranquilizers, antipsychotics, and cardiovascular drugs in the ensuing decades, the American pharmaceutical industry had come to play a dominant role in the public understanding of medical science, the economics of patient care, and the rising politics of consumerism. For Kefauver, the “captivity” of the prescription-drug consumer in the face of price gouging and dubious claims of efficacy under-scored the need for the state to ensure that innovative industries worked to the benefit of the average American.
The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT), carried out at more than 20 sites between 2004 and 2009, sought to identify, in infants born very prematurely at 24 to 27 weeks' gestation, the oxygen-saturation level within the range considered the standard of care that would minimize the risk of retinopathy of prematurity (ROP), a complication of oxygen therapy that can result in vision loss.2 When the study began, targeting an oxygen-saturation range of 85 to 95% was becoming standard clinical practice, and the American Academy of Pediatrics (AAP) later recommended this range in its 2007 guidelines. The SUPPORT researchers and institutional review boards (IRBs), practicing clinicians, and the AAP had no scientific evidence to expect a difference in mortality between the two treatment groups in SUPPORT — one with the oxygen saturation target of 85 to 89%, the other with the target of 91 to 95%.
Most European patients do not have access to innovative, high-risk devices as soon as the devices receive a CE marking. Each country must first make a decision about reimbursement, a process that varies substantially among countries.5 Though a CE marking can be granted on the basis of fewer clinical data than are required for FDA approval, European standards for reimbursement are often similar to or higher than those that the FDA imposes for device approval. European countries may require additional data on the device's safety and effectiveness, as well as on cost-effectiveness.
But controversies such as this are also an opportunity to advance shared understanding, provide clarification, and encourage progress. The public debate surrounding the SUPPORT study has set the stage for a substantive national dialogue with the research, advocacy, and ethics communities on how best to respect and protect participants in research studies conducted within the standard of care and how to define “reasonably foreseeable risks” in this setting. The timing is critical — the clinical research community, bioethicists, regulators, IRBs, and prospective research participants are paying close attention now. The NIH is happy to work with all stakeholders to advance this important dialogue and its translation into clear guidance, in accordance with the plan just announced by the DHHS (www.hhs.gov/ohrp/). In addition, a new letter to the University of Alabama at Birmingham from the OHRP, stating its intention to put all compliance actions on hold until the process of producing appropriate guidance is completed, is available now on the OHRP website (www.hhs.gov/ohrp/detrm_letrs/YR13/jun13a.pdf).
The amendments granted the FDA the power to demand proof of efficacy — in the form of “adequate and well-controlled investigations” — before approving a new drug for the U.S. market. They also led to a retrospective review of all drugs approved between 1938 and 1962 (the Drug Efficacy Study Implementation program), which by the early 1970s had categorized approximately 600 medicines as “ineffective” and forced their removal from the market. These market-making and unmaking powers were also tied to a new structure of knowledge generation: the orderly sequence of phase 1, phase 2, and phase 3 trials now seen as a natural part of any pharmaceutical life cycle.
It's important to provide adequate information to patients and prescribers. That's impossible if there are no good data, but sometimes data included in a drug-development dossier are not adequately reflected in the approval documents. There must be greater focus on the package insert, the regulatory document most widely referred to by the public, which must do a better job of explaining how to take the medication, whether dosage adjustments are advised for older patients, and what is known about use with concomitant medications.
After 17 months of hearings, in which pharmaceutical executives were openly berated for profiteering and doctors were portrayed as dupes of pharmaceutical companies' marketing departments, Kefauver presented his bill, S.1552. Perhaps its least controversial components were its calls for ensuring that the FDA review claims of efficacy before drug approval, monitor pharmaceutical advertising, and ensure that all drugs had readable generic names. More radically, Kefauver proposed completely overhauling the relationship between patents and therapeutic innovation. First, he proposed a compulsory licensing provision so that all important new drugs would generate competitive markets after 3 years. Second, and more controversial still, Kefauver wanted to eliminate “me-too drugs” and “molecular modifications” by insisting that a new drug be granted a patent only if it produced a therapeutic effect “significantly greater than that of the drug before modification.”1 Proving that a drug worked, according to Kefauver, was not enough: he wanted proof that a drug worked better than its predecessors. In contemporary terms, he wanted to know its comparative effectiveness.
In 2011, approximately 40.3 million people in the United States (roughly one eighth of the population) received an outpatient prescription for the macrolide azithromycin, according to IMS Health. During that year, we at the Food and Drug Administration (FDA) reviewed the labels of azithromycin and other approved macrolide antibacterials in view of cardiovascular risks that had become evident from published studies and reports emerging through postmarketing surveillance. On the basis of its review, the FDA approved revisions to azithromycin product labels regarding risks of QT-interval prolongation and the associated ventricular arrhythmia torsades de pointes. The revised labels advise against using azithromycin in patients with known risk factors such as QT-interval prolongation, hypokalemia, hypomagnesemia, bradycardia, or use of certain antiarrhythmic agents, including class IA (e.g., quinidine and procainamide) and class III (e.g., dofetilide, amiodarone, and sotalol) — drugs that can prolong the QT interval. In March 2013, the FDA announced that azithromycin labels had been further revised to reflect the results of a clinical study showing that azithromycin can prolong the corrected QT interval.
To compare the United States and Europe fairly on this front, three criteria must be considered: the level of device innovation, equivalent start and end points, and patient access as defined by time to reimbursement. First, we focused on innovative, high-risk devices because in the United States such devices require the strongest evidence of clinical benefit and are the subject of most debates about the relative effectiveness of approval processes in different countries. Furthermore, previous studies have shown that lower-risk devices achieve market access in a similar amount of time in the United States and in Europe.
First, the strategy recognizes that older people are the main users of medications — not a minority or special population (a fundamental difference between the geriatric and pediatric populations). Therefore, legislative and regulatory frameworks must be designed to ensure that the use of newly approved medicines in the intended population is supported by relevant data on the benefit–risk balance. The strategy's second aim is to improve the availability of information to patients and prescribers, to support safer use of medications.
But questions remain about the efficacy of fines and corporate integrity agreements in deterring corporate misbehavior. The 2012 fines against Abbott Laboratories and GSK represent a modest percentage of those companies' revenue.1 Companies might well view such fines as merely a cost of doing business — a quite small percentage of their global revenue and often a manageable percentage of the revenue received from the particular product under scrutiny. If so, little has been done to change the system; the government merely recoups a portion of the financial fruit of firms' past misdeeds.
Given continuing questions about the efficacy of the 300-mg product, the FDA decided to conduct, under its own auspices, the bioequivalence study described here. Because the results indicated that Budeprion XL 300 mg cannot be considered therapeutically equivalent to Wellbutrin XL 300 mg, the FDA requested that the sponsors of Budeprion XL (Impax Laboratories and Teva Pharmaceuticals) voluntarily withdraw the 300-mg version from the market, which they agreed to do.
The results of the FDA-sponsored study have led the agency to review its approach to other 300-mg extended-release generic bupropion products. The agency has determined that direct bioequivalence studies using the 300-mg strength of the brand-name and generic products are appropriate and feasible. Accordingly, the FDA has requested that other makers of generic extended-release bupropion hydrochloride (Anchen, Actavis, Watson, and Mylan) perform bioequivalence studies of their 300-mg products. The agency is also updating its bioequivalence guidance for these products. As new information regarding these products becomes available, the agency will take any appropriate regulatory actions and will inform the public. Patients who are taking the 300-mg strength of generic extended-release bupropion products and have questions about their medication should be encouraged to speak with their health care provider.
On July 2, 2012, the Department of Justice announced the largest settlement ever in a case of health care fraud in the United States. GlaxoSmithKline (GSK) agreed to plead guilty to three criminal counts and settle civil charges brought under various federal statutes; the company will pay a total of $3 billion to the federal government and participating states. Since 2009, the federal government has collected more than $11 billion in such settlements under the False Claims Act.
The process started in 2006, when the EMA provided an opinion on the adequacy of guidance on the elderly regarding medicinal products. In 2011, the agency's Committee for Human Medicinal Products adopted the EMA geriatric medicines strategy,1 marking its commitment to improving our understanding of how best to evaluate the benefit–risk ratio for a medication in older patients.
One must, of course, weigh any observed drug-associated risk against clinical benefits, so it's appropriate to consider the possibility that certain offsetting benefits of azithromycin may not have been reflected in the risk data analyzed by Ray et al. For example, other studies have suggested that macrolides have an advantage over other antibacterial agents in terms of overall survival from community-acquired pneumonia. In a recent Canadian observational study, researchers followed 2973 outpatients with community-acquired pneumonia and found significantly lower 30-day mortality among patients receiving macrolides than among those receiving fluoroquinolones (adjusted odds ratio, 0.28; 95% CI, 0.09 to 0.86).2 A recent meta-analysis of observational studies showed a statistically significant 25% difference in mortality among hospitalized patients with community-acquired pneumonia favoring macrolides over nonmacrolide antibacterials.3 Such findings, which must be considered with due regard for the limits of observational studies, do not necessarily contradict the results of Ray et al. Past the 5-day period of risk of azithromycin-associated cardiovascular death, the drug might reduce the longer-term (e.g., more-than-30-day) rate of death due to pneumonia. Pneumonia was an uncommon indication among the Tennessee Medicaid patients treated with azithromycin.
We investigated the most common ambulatory indications for azithromycin by analyzing data from a survey conducted by Encuity Research of approximately 3200 office-based physicians for the decade from 2002 through 2011. Across all age groups of patients, the two most common indications for azithromycin were chronic sinusitis and bronchitis. The tableAgents Associated with Drug-Use Mentions for Chronic Sinusitis and Bronchitis, According to U.S. Office-Based Physician Practices (January 2002–December 2011). shows the antibacterial drugs that were used most commonly in the United States for these indications. Azithromycin was the leading antibacterial drug for outpatient treatment of bronchitis during this period (even if amoxicillin is combined with amoxicillin–clavulanate). For chronic sinusitis, azithromycin ranked second after amoxicillin. Because the indications are reported by the prescribing physicians, these data don't allow us to assess the diagnostic certainty regarding the infections being treated.
Renewed attention to comparative effectiveness research in the 21st century illustrates the consequences of sidelining Kefauver's initial demand for comparative data for evaluating the promotion of novel therapeutics. By 2000, pharmaceutical expenditures had become one of the fastest-growing parts of the budget of many U.S. states and third-party insurers. But the kind of knowledge required for entry into the U.S. drug market offers consumers and payers little information relevant to choosing between subtly different “me-too” drugs within the same therapeutic class — whose therapeutic effect may or may not be the same. Only in the past decade, through the action of the Reforming States Group, the Drug Effectiveness Review Project, and most recently funding of comparative effectiveness research through the American Recovery and Reinvestment Act, the Affordable Care Act, and now the Patient-Centered Outcomes Research Institute, have we begun to catch up on the vital project of comparing therapeutics so that American consumers and their physicians can make meaningful treatment decisions — the project that motivated Kefauver's original investigations a half century ago.
Clinicians must consider the arrhythmogenic potential not only of azithromycin but also of potential alternative antibacterial drugs. An earlier study showed an association between the use of erythromycin and sudden cardiac death, augmented by concomitant use of inhibitors of the cytochrome P-450 3A isozymes that metabolize erythromycin.4 Labels for erythromycin and clarithromycin include warnings regarding QT-interval prolongation and arrhythmias. All labels for fluoroquinolone products similarly have warnings regarding QT-interval prolongation, and grepafloxacin was withdrawn from the market because of that risk. A recent observational study of elderly residents of Quebec, Canada, showed an association between outpatient fluoroquinolone use and serious arrhythmias (as defined by hospital discharge diagnoses of ventricular arrhythmia or sudden or unattended death).5 And although Ray et al. found the risk of cardiovascular death to be greater with azithromycin than with ciprofloxacin, they found the risk with levofloxacin similar to that with azithromycin. The authors interpreted this similarity as evidence that levofloxacin may be proarrhythmic; however, levofloxacin was not implicated as proarrhythmic in the Canadian study.
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