Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 98

FDA has various publications and feeds freely available without cost online, such as e-mail alerts and as RSS feeds. “What’s New (Drugs)” comes out several times a week with new drug-specific information. The relevant publications are well worth receiving, particularly the MedWatch and CDER notifications.

Others include the following:

CDER New: New items posted to the CDER website;

Drug Information: Occasional drug information updates on hot topics, frequently asked questions, and more;

Marketing and advertising communications: Drug marketing, advertising, and communication regulation information; updates to the Office of Prescription Drug Promotion web pages, which occasionally involve fair balance with safety matters;

Drug Safety News (Podcast alert): Emerging safety information about drugs, broadcast in conjunction with the release of Public Health Advisories and other drug safety issues;

Drug Safety Newsletter: Post-market information for healthcare professionals on new drug safety information and reported adverse events;

FDA Patient Safety News (video): TV broadcasts for healthcare professionals about recalls, alerts, and ways to improve the safety of drugs, medical devices, vaccines, and diagnostic products;

MedWatch Safety Alerts: Product safety alerts, Class I recalls, market withdrawals, and public health advisories;

FDA Guidance Documents for the industry;

FDA Warning Letters: FDA Warning Letters and untitled letters issued to companies, investigators, IRBs, etc.; and

Good Clinical Practice: Information about the development of final rules related to FDA’s regulations on good clinical practice and clinical trials. These reference the ICH E6 guideline, as revised.

The reports may change from time to time, with new ones introduced and old ones phased out. Check the FDA web site for updates. There are other alerts on biologics, CBER, and specific diseases and conditions, including HIV and infectious hepatitis, women’s health, medical devices, research, food contamination, and cosmetics.

This site offers sign-up for multiple subscriptions at the same time from various health and human services agencies and divisions, including the CDC, NIH, Med-Line Plus, and others.

The FDA, the industry, and nearly everyone else is now struggling with the newly and rapidly arising social media (Twitter, Facebook, LinkedIn, Buzz, blogs, bloginars, eCards, podcasts, widgets, virtual worlds, etc.). As of this writing, FDA had several Twitter feeds and a Facebook page, and is expanding its use of social media.

The FDA’s influence on life in the United States is extensive. The Agency oversees and regulates drugs, biologics, vaccines, dietary supplements, radiation-emitting devices, certain foods, cosmetics, and tobacco. They cover both human and veterinary products. FDA’s influence outside the United States is obviously less strong than within the United States but, nonetheless, is felt through direct and indirect actions in international entities (e.g., ICH, CIOMS, where FDA is a major player either directly or indirectly), formal and informal interactions and memoranda of understanding with other health agencies (Europe, Canada, Japan, China, etc.), and as a thought and action leader (e.g., a drug safety restriction or withdrawal in the United States must be addressed, in practice, rather quickly elsewhere around the globe). FDA also has an extensive network of offices outside the US (Mexico City, San Jose, Santiago, London, Brussels, New Delhi, Beijing, among others).

For those in industries regulated by the Agency, the FDA has an impact on actions every moment of the day in just about all areas of business:

Approval of INDs and NDAs, 510Ks, and so on;

Regulations covering all aspects of manufacturing (current Good Manufacturing Practices), clinical research (Good Clinical Practices), animal research (Good Laboratory Practices), quality systems, drug safety (Good Pharmacovigilance Practices), the supply chain(s), and so on;

Inspections (often unannounced) of factories, clinical trial sites, safety divisions, clinical trial divisions, licensing partners, contract research organizations, and so on;

Drug safety;

Product labeling and packaging;

Product advertising, sales promotion, and other professional communications;

Advice to the public; and

Communication to all stakeholders.

The FDA has multiple “clients” to which it must answer: the Secretary of Health and Human Services (in the President’s cabinet), the Congress (which provides funding and oversight), the American public, activist groups (consumer groups, lobbies, etc.), the media (press, TV, Internet, blogs, etc.), the pharmaceutical industry, other healthcare players, and, indirectly, foreign health agencies.

Pharmaceutical companies also have multiple clients but some are different: the stockholders (owners) of the company, the Securities and Exchange Commission, the American public, activist groups, the media, licensing partners, academic collaborators, trade groups, the FDA, and, for multinational companies, other health agencies, insurance companies and other payers, and foreign media.

The FDA’s fundamental viewpoint and raison d’être differ from those of pharmaceutical corporations. The FDA’s prime concern is protecting the American public (and animals). They are, in theory, not concerned with the viability or profitability of corporations or market share, whereas companies, again in theory, have a primary fiduciary goal of increasing shareholder value. Obviously, a company would not want to increase its stock price at the expense of the public health. But, in practice, decisions on what is good or bad for public health are almost never black and white. Rather, they are the subject of debate on the risks and benefits that usually fall somewhere in the gray area between the extremes. Nevertheless, it is in the interest of the public health for the public and healthcare community to have access to medical products when needed; all stakeholders should strive to ensure that the benefits of these products outweigh their risks.

Other factors come into play. In general, salaries and bonuses, particularly for professionals, are often better in private sector companies than in the FDA or academia. However, benefits, pensions, and retirement packages are often better in government service. Private sector companies tend to have more resources (people, computers, parking spaces, etc.) than government agencies.

As with other federal agencies, there is often a steady flow of personnel leaving the Agency to go to the private sector and, with the FDA, occasionally vice versa. This is generally viewed as a good phenomenon because it allows government workers to understand the functions and pressures in private industry and for private industry personnel to understand how government agencies function. Others feel this is a bad concept as it binds the regulators and the regulated too closely together and influences the actions of regulators who may want to get a job in industry after leaving the Agency. Many people enter the industry or the FDA from academia, often just after finishing training (in medicine, pharmacy, nursing, pharmacology, toxicology, statistics, IT, etc.) and, thus, the “first job” provides basic training that is essential for success in either industry or the government.

There is a continuing debate, which varies in intensity and persistence over time, on whether the FDA works too slowly (“drug approval lag”) or too quickly (“releasing dangerous drugs onto the market without adequate evaluation”) and whether there are too many regulations (“the biopharmaceutical industry is one of the most regulated or over-regulated industries in the United States”).

Most pharmaceutical companies live with a low-level dread of the FDA and other health agencies coming into their safety departments (or other departments) to do an inspection (unannounced as a rule when done by the FDA). The inspection may be routine, done periodically (often every 1 to 2 years) or “for cause” (wherein the FDA has a suspicion that all is not right). The inspection may last from a few days to months if major issues are found. The FDA may go to sites outside the United States, if appropriate. Conversely, the EMA and other agencies abroad inspect in the United States. However, most companies now understand that building quality management systems is now obligatory, not just in safety, but throughout the organization. They also realize that periodic audits (including self-audits) and governmental inspections are now part of the norm and “a cost of doing business”. Such inspections not only provide markers for compliance, but also serve to promote trust in medical products and the regulatory system.

There has been much controversy after the withdrawal of Vioxx and other products from the US market as well as contaminated products (e.g., heparin) for safety reasons. Some (both from within the FDA and from the outside) have accused the FDA of not sufficiently protecting the American public from “dangerous” drugs, food, and other products. There have been accusations of too rapid approval of drugs, insufficient analysis of data submitted to the FDA, companies’ not submitting complete or sufficient data to the FDA, and other charges. Similar controversies have been seen with other regulatory agencies in regard to financial regulation, air transport safety, and so forth. The PDUFA, FDAAA, and other changes are a result of these controversies. More will come.