Life after Enron and ImClone: Special concerns for the biotechnology company

10.5912/jcb39 ◽  
1969 ◽  
Vol 9 (4) ◽  
Author(s):  
Neil H Aronson
Keyword(s):  
Corporate Governance ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Securities And Exchange Commission ◽  
Critical Periods ◽  
Private Companies ◽  
Public And Private ◽  
Biotechnology Companies ◽  
Senior Officers ◽  
Public Offering

The recent enactment of federal legislation and the ongoing adoption of comprehensive regulations by the Securities and Exchange Commission (SEC) and stock exchanges create a new era for corporate governance. For public biotechnology companies, these new laws and regulations create specific concerns and significant criminal and civil sanctions. Private companies considering a public offering should also consider the implications of these statutes and regulations. In the future, investors are expected to reward both public and private companies that enact strong corporate governance practices.Biotechnology companies will need to carefully review and modify document retention, disclosure, compensation and stock trading policies to comply with the following new requirements:Document retention policies will need to address complex recordkeeping requirements imposed both by the Sarbanes–Oxley Act of 2002 (SOA) as well as a myriad of regulations imposed by the Food and Drug Administration and the Environmental Protection Agency.Severe penalties for improper certification by senior officers of SEC reports places added pressure on public biotechnology companies. Officers will need to establish systems to regularly review the accuracy of disclosures involving all intellectual property, regulatory and healthcare reimbursement disclosures in these periodic reportsCompensation plans for officers and directors must prevent future loans (and modifications to existing loans) and address corporate governance concerns now raised by institutional investors and the media.New reporting requirements for insider sales require that corporations develop systems to accurately track insider sales and to establish systems to prevent insiders and their family members from trading during critical periods preceding Food and Drug Administration and other regulatory actions.

Recommendations for Clinical Trials of Off-Label Drugs Used to Treat Advanced-Stage Cancer

2012 ◽  
Vol 30 (6) ◽  
pp. 661-666 ◽  
Author(s):  
C. Daniel Mullins ◽  
Russ Montgomery ◽  
Amy P. Abernethy ◽  
Arif Hussain ◽  
Steven D. Pearson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Administration ◽  
Randomized Clinical Trials ◽  
Technology Policy ◽  
Food And Drug Administration ◽  
Decision Makers ◽  
Public And Private ◽  
Off Label ◽  
The Us ◽  
Before And After

Purpose To provide recommendations to trialists and sponsors that guide the design and implementation of prospective postapproval clinical trials for oncology drugs used outside US Food and Drug Administration–labeled indications for treatment of late-stage cancers. Methods A meeting was hosted by the Center for Medical Technology Policy in Baltimore, MD, on November 12, 2009. Discussions during the meeting and key informant interviews were conducted before and after this stakeholder meeting. Peer review by multidisciplinary stakeholders was followed by a public comment period. Input was received from patient advocacy groups, medical oncologists, pharmaceutical companies, the US Food and Drug Administration, Centers for Medicare and Medicaid Services, the National Cancer Institute, foreign government agencies involved in health technology assessment, public and private payers, drug compendia, clinical research entities, statisticians, academics, and the American Society of Clinical Oncology. Results To address the needs of patients and their clinical providers, compendia, payers, and policy makers, recommendations are proposed to guide the design of future prospective trials for off-label use of oncology drugs across four areas: trial design and data analysis, patient and site recruitment, comparators, and outcomes. Conclusion The US Food and Drug Administration provides guidance to the pharmaceutical industry and others designing randomized clinical trials for regulatory approval. However, a gap exists for postregulatory decision makers, including patients, prescribers, and payers, because regulatory trials do not answer the questions most relevant to them. Therefore, guidance is needed for trials performed in the postapproval environment for these postapproval decision makers.

Auditors' Response to Auditor Business Risk: An Analysis Using Public and Private Companies

2021 ◽  
Author(s):  
Gil S. Bae ◽  
Seung Uk Choi ◽  
Jae Eun Lee
Keyword(s):  
Initial Public Offering ◽  
Risk Premium ◽  
Audit Fees ◽  
Business Risk ◽  
Difference In Differences ◽  
Private Companies ◽  
Public And Private ◽  
Public Companies ◽  
Public Offering ◽  
Time Series Comparison

Using audit hours and hourly audit fees for a large sample of public and private companies, we examine how auditors respond to auditor business risk. We find that auditors work more hours and charge higher hourly fees when auditing public companies than when auditing private companies. A difference-in-differences time-series comparison of the pre- and post-initial public offering (IPO) periods also indicates that both audit hours and hourly audit fees are higher for the post-IPO period than for the pre-IPO period of the company. This suggests that auditors respond to an increase in auditor business risk by increasing audit effort and charging a risk premium for the residual risk that additional effort alone does not fully address.

scholarly journals Privately-Held Companies: Legislation, Regulation, and Limited Dissemination of Financial Information

2019 ◽  
Vol 47 (4) ◽  
pp. 28
Author(s):  
Zoeanna Mayhook
Keyword(s):  
Financial Statements ◽  
Securities And Exchange Commission ◽  
Financial Information ◽  
Publicly Traded ◽  
Private Companies ◽  
Public And Private ◽  
Publicly Traded Companies ◽  
The Public ◽  
Disclosure Requirements ◽  
Privately Held

Publicly-traded companies have reporting and disclosure requirements set by the U.S. Securities and Exchange Commission (SEC), which includes the public disclosure of financial statements and an annual 10-K report. In contrast, privately-held companies most often do not meet the SEC filing requirements, and therefore, are not required to disclose financial information. For investors and business researchers, this can provide clear challenges for researching privately-held companies. This paper first highlights a sample of the significant legislation and rules affecting disclosure requirements of public and private companies. Then, it offers other government sources for company and industry financial information. Finally, it suggests further resources to educate business owners, investors, and business researchers.

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