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The article focuses on the Accelerated Approval Program for cancer drugs and the need to strike the right balance between expediting drug approvals based on surrogate measures and ensuring clinical benefits are confirmed in subsequent trials. Topics include the challenges and issues with the current program, proposed changes to the program, and the importance of safeguarding patient interests while accelerating drug development.

The article discusses the potential impact of Medicare price negotiations on cancer drug launches. It mentions that the Inflation Reduction Act (IRA) could lead to delays in the release of new cancer drugs, especially those with limited indications.

The article emphasize the crucial role of laboratory-developed tests in patient care, particularly in academic medical centers and caution against restricting beneficial tests. They advocate for a balanced regulatory approach, acknowledging the need for improved safety and effectiveness while ensuring continued access to essential testing.

The article reports that Health law is slow-moving accretive, but it also shapes the landscape of health care delivery in powerful ways. Since implementation of the law requires democratic deliberation, administrative oversight, and judicial enforcement, health law is often a lagging indicator of the norms of health care practice.

The article presents the discussion on Food and Drug Administration (FDA) facing a regulatory decision. Topics include offering insight to agency leaders facing difficult decisions for approving a drug for marketing or permitting a drug to remain on the market; and consisting of a conclusory sentence stating the application not raising important safety or efficacy issues.

The article discusses promoting pediatric drug research for the treatment of children. Topics include the first law which imposing federal regulations of biologic products was the Biologies Control Act of 1902; modern-day drug regulatory system which requires certain scientific and clinical testing of drugs and biologic agents; and use of the drug for the treatment of children with pulmonary arterial hypertension.

The article focuses on announcement of pharmaceutical company leaders on September 8, 2020 that they would refuse to apply for approval of a Covid-19 vaccine until adequate trial data are available. Topics include examines that manufacturers have criticized the Food and Drug Administration (FDA) for being too slow and demanding too much evidence before approving new products.

The article reports that Despite medicine's long-standing reputation as a largely self-regulated profession, U.S. medicine in fact has a multifaceted and significant relationship with the law. Medical evidence and physicians themselves may directly influence legal decisions and trends, but more pervasively, statutes, regulations, court rulings, and requirements imposed by multiple levels of government profoundly shape U.S. medical practice.

The article discusses the approval of U.S. Food and Drug Administration (FDA) on the new drugs which predicts clinical benefits. Topics mention including the drug manufacturers who commits on conducting a postapproval trials which confirms the efficacy of drugs, revision of drug labelling and several drugs which are selected and have received the accelerated approval since 2011 with their cost.

The article informs about the free-trade deals with countries, which is concluded by the U.S., and includes terms affecting the approval process and availability of medicines. Topics include pharmaceutical patent protection and other guarantees of exclusivity provided by the participating countries, trade efforts to secure enforceable commitments on protecting patents, and shifting of manufacturing and ownership of drug companies patents to low-tax countries so as to avoid paying U.S. taxes.

The article focuses on the proposal of the government of Massachusetts for a shift of 140,000 near-poor adults from Medicaid into private plans on the state's health insurance marketplace. It provides overview of the conditions of the reform which aims to create a closed drug formulary for Medicaid to manage the state's budget, improve care, and reduce cost. It notes that the proposal was headed by Governor Charlie Baker, who has opposed national efforts to repeal the Obamacare.

The article discusses data-sharing pathways for research purposes under the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH). Topics include the usefulness of HIPAA and HITECH, application of the pathways for postapproval research, and the associated risk of liability among investors seeking to combine large data sets to conduct postapproval research.

The article focuses on the eroding judicial deference to the Food and Drug Association (FDA) and its consequences for public health. Topics include FDA has operated with deference from courts enshrined by the Supreme Court's landmark case Chevron U.S.A. v. Natural Resources Defense Council; and decisions of the Supreme Court regarding the Environmental Protection Agency and the Occupational Safety and Health Administration (OSHA) will have sweeping implications for public health agencies.

The authors reflect on the regulation of off-label promotion of drugs, highlighting the case of pharmaceutical sales representative Alfred Caronia, who promoted sodium oxybate for off-label use. Topics include the clinical trials required by the Food and Drug Administration (FDA) to demonstrate the safety and efficacy of the drugs, the misbranding of non FDA-approved drugs and the guidelines released by the drug and biologics industry for off-label promotion.

The article discusses the U.S. Supreme Court case Association for Molecular Pathology v. Myriad Genetics which deals with patenting human genes. It says that the court's decision was focused on the definitions of the genetic and patent codes, in which all nine Justices have agreed that the DNA segments making up human genes are not patentable under section 101 of the Patent Act2. Furthermore, the implications for health care and the biotechnology industry are discussed.

The authors comment on the financial link between pharmaceutical firms and health care professionals based on data from the Massachusetts Department of Health and Human Services. According to the data, the average total payment per physician during the 2010-11 period rose from 4,637 dollars to 4,944 dollars. The authors point out a possible explanation for the decline in overall payments and numbers of physicians during the period. Information on the Physician Payment Sunshine Act is given.

Background: The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians' reactions to trials with a high, medium, or low level of methodologic rigor. Methods: We presented 503 board-certified internists with abstracts that we designed describing clinical trials of three hypothetical drugs. The trials had high, medium, or low methodologic rigor, and each report included one of three support disclosures: funding from a pharmaceutical company, NIH funding, or none. For both factors studied (rigor and funding), one of the three possible variations was randomly selected for inclusion in the abstracts. Follow-up questions assessed the physicians' impressions of the trials' rigor, their confidence in the results, and their willingness to prescribe the drugs. Results: The 269 respondents (53.5% response rate) perceived the level of study rigor accurately. Physicians reported that they would be less willing to prescribe drugs tested in low-rigor trials than those tested in medium-rigor trials (odds ratio, 0.64; 95% confidence interval [CI], 0.46 to 0.89; P=0.008) and would be more willing to prescribe drugs tested in high-rigor trials than those tested in medium-rigor trials (odds ratio, 3.07; 95% CI, 2.18 to 4.32; P<0.001). Disclosure of industry funding, as compared with no disclosure of funding, led physicians to downgrade the rigor of a trial (odds ratio, 0.63; 95% CI, 0.46 to 0.87; P=0.006), their confidence in the results (odds ratio, 0.71; 95% CI, 0.51 to 0.98; P=0.04), and their willingness to prescribe the hypothetical drugs (odds ratio, 0.68; 95% CI, 0.49 to 0.94; P=0.02). Physicians were half as willing to prescribe drugs studied in industry-funded trials as they were to prescribe drugs studied in NIH-funded trials (odds ratio, 0.52; 95% CI, 0.37 to 0.71; P<0.001). These effects were consistent across all levels of methodologic rigor. Conclusions: Physicians discriminate among trials of varying degrees of rigor, but industry sponsorship negatively influences their perception of methodologic quality and reduces their willingness to believe and act on trial findings, independently of the trial's quality. These effects may influence the translation of clinical research into practice. [ABSTRACT FROM PUBLISHER]

The article reports that Gene therapies aim to ameliorate or cure disease by altering part of the patient's genome by replacing, deleting, or inserting genetic material Gene therapies are associated with exceptionally high costs, which can impede patient access and strain healthcare budgets. It mentions various treatments that have been approved by Food and Drug Administration, including voretigene neparvovec (Luxturna) for treating retinal dystrophy and onasemnogene abeparvovec (Zolgensma).

The article discusses the controversy over the legality of the so-called pay for delay settlements to resolve disputes over drug patents in the U.S. The Federal Trade Commission (FTC) has called for making some pay-for-delay settlements presumptively illegal. The role played by the Hatch-Waxman Act of 1984 and the so-called Paragraph IV challenges in the emergence of the controversy is explained. Other topics discussed are concerned with antitrust law and the availability of generic drugs.

The article explores the legal aspects of the trade dress in relation to pills. It notes that consumers need to accept that generic pills have differences in terms of size, color and shape, depending on the supplier. It cites several criteria that a trade dress needs to meet which include being nonfunctional, can cause confusion and having a secondary association with the product for the consumer. It is said that innovator firms use trade dress to be able to retain their share of the market.

The article examines the origins and effects of legislation supporting market-exclusivity incentive programs in pharmaceutical research and development in the U.S. Among the policy initiatives are the Bayh-Dole Act of 1980, the Orphan Drug Act of 1983, and the Waxman-Hatch Act in 1984. The need for incentive programs to be implemented in a way that fosters fairness is stressed. Cited are secondary consequences of using market exclusivity to encourage useful public health goals.

The author reflects on the criticisms being faced by Myriad Genetics concerning its patents for breast cancer 1, early onset (BRCA1) and breast cancer 2 susceptibility protein (BRCA2) genes and their importance to the screening of breast and ovarian cancer risk. Several patent claims of Myriad were invalidated by a U.S. federal district court judge due to the patentability issue of genes. There is said to be a limitation in the exclusivity of a company's control of composition of matter, manufacture, machine, or process in accordance with the Patent Act.

In this article, the authors discuss a study concerning the experiences of whistle-blowers in legal cases focusing on health care fraud in the U.S. The study procedure included the identification of federal qui tam cases involving pharmaceutical companies with the help of the Civil Division of the U.S. Department of Justice. The fines being imposed on violators ranged between 5,500 and 11,000 U.S. dollars in accordance with the False Claims Act (FCA) in the U.S. Commonalities in whistleblowers's experiences identified in the study are discussed.

In 2015, U.S. government agencies began considering greater regulation of both homeopathic drugs and the advertising of such products. These actions came after more than a century of missed opportunities to regulate homeopathic medicines. [ABSTRACT FROM AUTHOR]

In this article, the author expresses his views on the oral arguments heard by the U.S. Supreme Court in the case Bilski v. Kappos on November 9, 2009 concerning process patents and medical innovation. They note that the arguments were focused on the legitimacy of a patent on a hedging risk method in commodities trading which will result to health care issues. They presents a definition of patents in accordance to the provisions of the Patent Act.

The authors reflect on a proposal from the U.S. Food and Drug Administration which would change its rules governing pharmaceutical promotion and would widen the ability of drug manufacturers to distribute information on unapproved uses of their products. They suggest that research done on promotional statements has shown that some drug manufacturers have depicted the risks and benefits of their products inaccurately. They argue that off label promotion may impede rigorous scientific study.

The article presents an overview of the protein based therapeutics market, which began with the approval of recombinant human insulin (Humulin) by the U.S. Food and Drug Administration. A discussion off the advantages and disadvantages of protein based therapeutics and generic alternatives to them, and on U.S. Congressional plans to regulate and control protein based therapeutics, is presented. Research which has been conducted on protein based therapeutics and laws passed by the U.S. Congress concerning their use are discussed.

The article offers information on the 21st Century Cures Act which was approved by the U.S. House of Representatives. Topics include the bill's ability to push for the development of new drugs, possible increases in the budget of the National Institutes of Health (NIH), and the establishment of the NIH Innovation Fund. It also discusses the need for the faster approval for new drugs, the involvement of the Food and Drug Administration (FDA), and the use of adaptive trial designs.

The authors reflect on the medical device excise tax, a 2.3 percent tax on domestic sales of medical devices in the U.S. The uncertainty facing this source of funding for the Affordable Care Act (ACA) is highlighted. Where the excise tax came from and why it is in danger of repeal are explored. What the repeal would mean for the ACA is discussed.

The article discusses the U.S. Supreme Court case Pliva v. Mensing, which concerns the failure of metoclopramide manufacturer Pliva to warn physicians and patients about the risk of tardive dyskinesia associated with its long-term use. The Supreme Court ruled that brand-name drug manufacturers had a duty to update their labels, however, Pliva is not liable in state court for not updating their labels to integrate new warning information since it is a generic drug manufacturer.

The article discusses the U.S. Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA). The Act extends user fees to generic drugs manufacturers in order to offer greater funding for FDA's generic-drug reviewers. It ensures that FDA will receive the user-fee funding that it needs to help promote review efficiency. However, the author argues that the ACT failed to promote more robust postmarketing systems to validate the effectiveness and safety of marketed products.

The article discusses the U.S. Supreme Court's ruling on the case of Mayo Collaborative Services v. Prometheus Laboratories which is expected to change the role of patents in biomarker discovery and clinical application. The background of the case is provided. Under the U.S. law, patents for processes or methods that meet the other requirements in the patent statute are permitted. The court prescribed patents from covering correlations used in making biomarker-based diagnoses.

The article discusses a Supreme Court case involving the Stanford University and Roche Molecular Systems regarding ownership of a diagnostic assay for human immunodeficiency virus (HIV). The arguments of Stanford University and Roche in the case are highlighted. Supreme Court Chief Justice John Roberts ruled that the inventor has always held the primary position. Such ruling emphasizes the importance of intellectual-property-related language in agreements signed by academic scientists.

The authors explore the issue of whether U.S. medical residents should be considered workers or students. They discuss the case of Mayo Foundation for Medical Education and Research, et al. versus United States. They examine the controversy over the 1935 Federal Insurance Contributions Act (FICA). The authors also discuss government lawyers' defense of the Treasury regulation that declares residents to be employees.

The article discusses the substantial role of social media Web sites in the marketing of pharmaceutical products, as well as the need to regulate such media advertising to ensure the safety of the consumers who access information on such media. It cites the efforts being done by the Food and Drug Administration (FDA) to monitor the drug labels of various products as a tool to protect the public's health. It presents the seal of approval that was introduced by the American Medical Association (AMA) to authenticate the information.

In this article, the author expresses his views on issues related to the decision made by the U.S. Food and Drug Administration (FDA) to grant market exclusivity to URL Pharma for the colchicine drug. Colchicine is a drug manufactured by URL Pharma for the treatment of acute flares of gouty arthritis. Information on the 1938 Food, Drug, and Cosmetic Act is also presented.

The authors examine the plan of the U.S. Congress to change the focus of the Waxman & Hatch Act on biologic drug products with molecules often produced from living cells. They note that the legislation successfully balanced the public interest in offering sufficient incentives for investment in innovation in affordable medications. They assert the possible consequences of the new law and argue that a 12-year market exclusivity period for existing patent rights could mean ignoring recommendations from the Federal Trade Commission (FTC) by Congress.

The article discusses the U.S. Supreme Court case of Wyeth V. Levine regarding liability protection for pharmaceutical manufacturers based on the approval of a drug's label by the U.S. Food and Drug Administration (FDA). The FDA argued that preemption could extend to health care practitioners. The author explains the relationship between product liability and medical malpractice. He believes that it would be unlikely that preemption would lead to new avenues of liability for physicians.

The author expresses his concerns about a program implemented by the U.S. Food and Drug Administration (FDA) Amendments Act of 2007 which promotes the development of pharmaceutical products for neglected diseases. Sponsors of a drug for a tropical disease are given vouchers for expedited FDA review of a drug application. The author believes the program is inefficient. He also believes that FDA review which is too speedy may lead to bad regulatory decisions. Alternative approaches are discussed.

The article reports that legislation permitting the U.S. government to negotiate Medicare drug prices has been weakened after pushback from the pharmaceutical industry. Topics include government's costs for filling prescriptions in federal programs; and medications by means of the National Institutes of Health (NIH) to fund biomedical research.

A response from the authors of the Perspective article on the 21st Century Cures Act published in the June 25 issue is presented.

The article presents the Watchman Left Atrial Appendage Closure System designed as the most intensely studied device for thromboembolic prophylaxis in patients with nonvalvular atrial fibrillation. Topics discussed include a Food and Drug Administration (FDA) advisory committee review of findings from manufacturing, bench and clinical testing of the device and the importance of timely data on real-world experience to complement clinical-trial evidence to understand a technology like Watchman.

The article presents a reprint of the article "Prescription Drug Coupons: No Such Thing as a Free Lunch," by Joseph S. Ross and colleagues, posted at NEJM.org on August 28, 2013. The article analyzes the effect of drug coupons on health care costs in the U.S. The study involving coupons from the online drug coupon repository www.internetdrugcoupons.com shows that median monthly manufacturer subsidy was 60 dollars. It asserts that coupons cannot offset higher long-term costs due to time limits.

A response by A. S. Kesselheim and D. H. Solomon to a letter to the editor about their article "Incentives for Drug Development--The Curious Case of Colchicine," in the June 3, 2010 issue is presented.

A response by Alfred B. Engelberg and Aaron S. Kesselheim to a letter to the editor about their article "Balancing Innovation, Access, and Profits: Market Exclusivity for Biologics" in the November 12, 2009 issue is presented.

The article presents a letter to the editor from the authors of the article "Supreme Court, preemption, and malpractice liability" published in the February 5, 2009 issue responding to a letter by Robert G. Hauser.