Pharmaceuticals

Pharmaceuticals in the United States

Legal Materials

The best-known drug reference source is probably the Physicians’ Desk Reference, available in print, on Westlaw (PDR) and on PDR3D. Also notable are The Merck Index(Merck Publishing), AHFS Drug Information (AHFS), DRUGDEX (available throughMicromedex), Facts and Comparisons and Lexi-Drugs.

The U.S. Food and Drug Administration provides information on approved drugs through Drugs@FDA and in the Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

The National Association of Boards of Pharmacy publishes an annual by the Survey of Pharmacy Law that is effectively a 50-state-survey of laws governing the industry.

You can get more online drug information from Medlineplus, RxList, Epocrates Onlineand United States Pharmacopeia. Information on Homoeopathic drugs is available from HPLUS Online, with includes the The Homoopathic Pharmacopoia of the United States, Homeopathic Good Manufacturing Practices, and related materials.

Note: There are also “special” PDRs, notably PDR Generics, PDR for Nonprescription Drugs and PDR Medical Dictionary. Like the main PDR, they are all published and sold by Medical Economics. And Westlaw has historical editions of the regular PDR back to 2006.

To see how effective a drug is compared to its peers, see the AARP’s Effectiveness and Safety of Prescription Drugs and/or Consumer Union’s Best Buy Drugs.

You can search for drug-related news articles using the Pharmaceutical And Health Industry News and the ESPICOM Pharmaceutical & Medical Device News databases on ProQuest Dialog.

Clinical Trials: To see which drugs are under development, check out the list of clinical trials posted at Center Watch, Healthline, Clinicalconnection.com, and/or ClinicalTrials.gov. Subscription sources include BioMedTracker and Pipeline Watch by Scrip Intelligence.

Licensing: To find out whether a pharmacist, pharmacy or drug distributor is licensed in a particular state, contact the relevant state Board of Pharmacy and/or check their Web site. Lists of Pharmacy Boards are posted by the National Association of Pharmacy Boards (NAPB) and hireRx. Licensing requirements are summarized in the annual Survey of Pharmacy Law by the NAPB.

License and Supply Agreements: Pharmaceutical License Agreements and Supply Agreements for public companies are retrievable by searching the exhibits in a goodSEC filings database.

Manufacturers and Pricing: To find out who manufactures a drug, look in Drug Facts and Comparisons and/or the Drug Topics Redbook. To find the biggest drug companies, the Scrip Intelligence League Tables rank the top companies by revenue, growth, sales, profit, etc.. The current price of drugs are posted online at Medicare.gov. For historical prices, look in back volumes of the annual Drug Topics Redbook(Medical Economics) or the monthly Price Alert (Medi-Span). Comparable pricing information is available in electronic format for a flat fee from Medi-Span and First Databank. Note: First Databank stopped publishing the “Blue Book” (i.e., the Essential Directory of Pharmaceuticals) in the late 1990s.

News: While some pharmaceutical news is reported in the general press, there are also specialty publications. Notable publishers include Elsevier and Scrip Intelligence, both discussed below.

Informa publishes a series of “Sheets” that provide news targeted to segments of the pharmaceuticals industry. These include: The Blue Sheet (government and private biomedical research programs); The Gold Sheet (pharmaceutical manufacturing); The Gray Sheet (medical devices); The Green Sheet (pharmacy) The Pink Sheet (prescription and over the counter pharmaceuticals); The Rose Sheet (toiletries and skin care products); and The Tan Sheet (non-prescription drugs and nutritional products). Articles are available through Pharma & MedTech Business Intelligence(formerly Elsevier Business Intelligence). Most of the Sheets are also available through some Lexis subscription plans.

Scrip Intelligence covers pharmaceutical business news including M&A, IPOs, deals, executives, lawsuits, as well as new drugs and clinical trials.

New FDA drug approvals are reported in Pharmaceutical Approvals Monthly and Scrip Intelligence.

Patents: You can look up the patents protecting a specific drug in the Orange Book. Search for the drug name, pull up the record, then click on the “Patents and Exclusivity” link.

Safety & Recalls: To check on a drug’s safety record in the U.S., check the FDA’s Index to Drug-Specific Information, Recalls, Market Withdrawals, & Safety Alerts and the FDAble Search for Drug Adverse Events. Also check the private AdverseEvents database.

Sales figures: Public companies report sales of the major drugs in their annual reports (10-Ks, 20-Fs, etc.). More detailed information may be available in Market Researchreports. Each Spring the periodical Drug Topics runs an annual list of the “Top 200” U.S. brand name and generic drugs by sales and by units in a number of markets (retail sales, hospitals, etc.). Sales figures are also published in Chain Drug Review,Drug Week and Drug Store News. Additional sources for information include news databases, analyst reports and annual reports by leading pharmaceutical companies.

IMS Health compiles data on U.S. and international drug sales but sell them only to subscribers.

See also the separate entry for Market Share.

Testing: The leading book on laboratory testing is the Laboratory Test Handbook by Jacobs & DeMott. Another notable book is Mosby’s Diagnostic and Laboratory Test Reference. To find other books on how to test for pharmaceuticals use the subject heading, “Diagnosis, laboratory — Handbooks.” To find books on how to test for illegal drugs, use the subject heading, “Drugs — Testing.”

Warning Letters: U.S. Food and Drug Administration Warning Letters are available through the FDA Web site and through a number of Thompson online subscription products, including the FDA Enforcement Manual.

IND filings

Drug companies are required to file information about the testing of their new drugs with the Food & Drug Administration. These are called IND filings. AIDS-related IND filings are sometimes available from the FDA’s FOIA office (301-443-1813). Other INDs generally are not. Information considered a “trade secret” never is.

Foreign Resources

Non-U.S. sources for researching pharmaceuticals include:

  1. The European Medicines Agency
  2. UK Medicines and Healthcare Products Regulatory Agency
  3. The British National Formulary (free in the UK or by subscription throughMedicinesComplete)
  4. eMC (U.K.)
  5. The Medicines Evaluation Board (Netherlands)

US State Pharmaceutical Assistance Programs Resources

Updated June 6, 2008

Prescription drug assistance has been a substantial and growing state interest for a number of years, generally in response to residents who lack insurance coverage for medicines or who were not eligible for other government programs.  In fact, the first states to authorize and fund direct subsidy programs did so in 1975.  Between 2000 and 2006 at least 26 states authorized and/or started pharmaceutical assistance programs, many intended to aid low-income elderly or persons with disabilities who do not qualify for Medicaid.  As of January 2008, at least 42 states had established or authorized some type of program to provide pharmaceutical coverage or assistance.  The subsidy programs, often termed “SPAPs,” utilize state funds to pay for a portion of the costs, usually for a defined population that meets enrollment criteria.  In addition, an increasing number of states use discounts or bulk purchasing approaches that do not spend state funds for the drug purchases, listed as “Discount Programs” below.

CHANGING NUMBERS AND FEATURES:

  • 38 states have enacted laws to create programs; others were created by executive branch action only.
  • 31 states have programs in operation as of February 2008.
  • 22 operational programs provide for a direct subsidy using state funds; in the past five years 36 states’ laws (plus DC) authorized such subsidies.
  • Wisconsin engaged in intense negotiations in 2007 regarding their subsidy program; a renamed program,  WisconsinCare, began January 2008.
  • 27 states created or authorized programs that offer a discount only (no subsidy) for eligible or enrolled residents; of these about 18 are in operation.  The latest are in Colorado and Florida, starting in 2008.  Some of these states also have a separate subsidy program.
  • Several programs ceased operation in January 2006, to be replaced by Medicare Part D plans.  These include Florida, Kansas, Michigan, Minnesota and North Carolina, plus a discount plan in Arkansas and South Carolina.  Recent but non-operational programs are listed below, with details in an NCSL Rx Archive Appendix for comparative and historical reference.

US Recent State Laws About Expanding Pharmaceuticals through 340B Resources

Although safety net health facilities have existed for decades, states’ searches for solutions to high prescription drug costs have led to new laws authorizing expanded use of the 340B programs. Examples include:

NOTE: Some hyperlinks below may not be active, depending on the state’s archive/database system.  We try to keep these links as up to date as possible. We appreciate your feedback.

  • Arkansas HB 2498 of 2001 authorizes expanded use, creation or designation of federally qualified health centers to get “substantially discounted prescription drug prices.”
  • California AB 77 Would authorize the Department of Corrections to establish a pilot project to determine whether the department may reduce the cost of providing health care to inmates, including the furnishing of prescription drugs to inmates at the 340B discounted price, by contracting for the provision of those health care services from certain covered entities.(Signed by governor as Chapter 503, 10/4/05)
  • California SB 340 of 2001. Expands dispensing options for California safety net clinics; §4126 authorizes 340B eligible clinics to contract with a community pharmacy to dispense 340B drugs. (As of January 2004, 59 clinics have contract pharmacy agreements.) (Signed by Governor Davis as Chapter 631, 10/8/01)
  • California SB 708 of 2005 Requires the State Department of Health Services to develop a standard contract for private nonprofit hospitals whereby a hospital agrees to provide medical care to indigent patients, as a condition of participation in the 340B drug discount program established under federal law.
  • Connecticut SB 1123 of 2003. Provides loans to federally qualified health centers for the cost of establishing a pharmacy facility or a partnership with a community pharmacy to serve as a centralized prescription drug distributor for federally qualified health centers that have established affordable pharmaceutical drug programs for qualified low income patients of such centers. The Commissioner of Social Services will assist any federally qualified health center that is applying for a loan by providing non-individual identifying information concerning potential participants in the affordable pharmaceutical drug program.
    (Signed by Governor as Public Act 03-166, 6/10/03)
  •  Maine HP 1591 / LD 2231 of 2008 by Rep. Treat requires the Governor’s Office of Health Policy and Finance to “coordinate with the Department of Health and Human Services and other state agencies and representatives of state employees, health care providers and federally qualified health centers to identify opportunities no later than July 1, 2009 to provide prescription drugs through Section 340B for the following, if the costs of implementing such a plan are less than the current cost of providing prescription drugs: 1) State-funded managed care plans; 2) MaineCare (Medicaid); 3) State bulk purchasing initiatives and 4) Populations using high-cost chronic care and specialty drugs.  Also requires the Department of Corrections to convene a working group to maximize use of the 340B. The effective date is April 16, 2008.  (Filed 2/26/08;passed House and Senate 4/15/08; signed by governor as PS Chapter 43, 4/16/08)
  • Maine HP 923 / LD 1324  Among other things, Would establish the Pharmacy Cost Management Council to develop and implement measures to control the cost of prescription drugs and expand the State’s purchasing power, pooled purchasing for public sectors and including employers, use of PBMs, PDLs, disease management, and research purchasing and coordination of benefits related to maximizing use of federal programs (Medicare, 340B) and purchasing from outside the US. (Signed into law by governor as Chapter 343, 6/8/05)
  • Maine LD 711 of 2003. Legislative resolve requires the Department of Human Services to study and report on “the feasibility of providing discounted prescription drugs to Maine’s most vulnerable patient populations through the use of Section 340B” by January 1, 2004. [text below] (Signed by governor as chapter 29, 5/19/03)
  • Maine LD 46 of 2003. Allows certain health care facilities that provide primary and preventive care services to purchase through state agencies or state contracts, prescription drugs and medical supplies for patients to whom they provide free care.
    (signed by governor as Chapter 79, 4/25/03)
  • Maryland HB 6 of 2001 requires the state to study the feasibility of purchasing prescription drugs through federally qualified health centers.
  • New Mexico SJM 35 of 2002 requests the state Medicaid, Human Services Department and others to “identify all avenues to maximize prescription drug discounts that may be achieved by using the federal 340B program.”
  • New Mexico SB 338, now Chapter 315 of 2003.  Requires Medicaid to “identify entities that are eligible to participate in 340B. “The department shall make a reasonable effort to assist the eligible entities to enroll in the program and to purchase prescription drugs under the federal drug pricing program. The department shall ensure that entities enrolled in the federal drug pricing program are reimbursed for drugs purchased for use by Medicaid recipients at acquisition cost and that the purchases are not included in a rebate program.”  Range of General Fund Savings $500,000-$1.5 million.
  • New Mexico HB 88 of 2004 ensures that all eligible entities participate in the federal drug pricing program under Section 340B of the federal Public Health Service Act.  Allows entities receiving greater discounts to opt out.
  • New YorkA 7298 of 2005 implements the 340B pharmacy savings program.  Prohibits state Medical Assistance payments to 340B covered entities or to contracted pharmacies for drugs that are eligible for purchase through 340B by outpatients. (Filed,passed House, passed Senate 4/12/05; signed by governor 4/13/05 as Chpt. 63)
  • Texas HB 2292 of 2003 among other things, provides that “community mental health centers may form a referral relationship with community health centers, federally qualified health centers, disproportionate share hospitals, and/or other eligible entities for the purpose of obtaining federal 340B pricing for pharmaceuticals.” Allows such referrals to “other lower cost drug programs regardless of any statewide preferred drug list or vendor drug program which may be adopted.” (§ 2.152.)
  • Texas HB 915 of 2001 creates the Interagency Council on Pharmaceuticals Bulk Purchasing, which must investigate options for using the 340B program: “The council shall investigate any and all options for better purchasing power, including … using rebate programs, hospital disproportionate share purchasing, and health department and federally qualified health center purchasing.”
  • Texas SB 347 of 2001 authorizes the Texas Department of Criminal Justice to provide prescription drug services to the Texas prison population through the 340B Prescription discount program. The law establishes a contract with two university hospital pharmacy systems that are qualified as providers within the 340B program. The law became effective October 1, 2001.
  •  UT  H 74 text of 2008 by Rep. Litvack requires the Department of Health and Human Services to explore the feasibility of expanding the use of 340B drug pricing programs in the state Medicaid program, which limits the cost of covered outpatient drugs to federally qualified health centers including consolidated health centers, migrant health centers, health care for the homeless, Healthy Schools/Healthy Communities and Tribal Programs.
    (Prefiled 12/14/07; passed House 1/23/08; passed Senate 2/7/08; signed into law by governor 3/14/08 )
  • Utah HB 33 of 2005 creates a five-year pilot program within the Comprehensive Health Insurance Pool Act for disease and pharmaceutical management of bleeding disorders; permits enrollees in the pilot program to participate in a federal 340B discounted drug pricing program; requires the Pool to report pharmaceutical costs under the pilot program.
  • Vermont H 768 (Appropriations bill) of 2004 among other things, would study the use and potential expansion of using 340B purchasing in the state for correctional facilities, state funded managed care plans and state bulk purchasing initiatives.(Signed by the governor 6/10/04)http://www.leg.state.vt.us/docs/legdoc.cfm?URL=/docs/2004/acts/ACT122.HTM see Sec. 128g.  33 V.S.A. § 2008

See Also

Chemicals
Drugs Prohibition
Market Research
Market Share
Medical Materials
Science
Engineers
Vitamins
Medical Materials
United States Food and Drug Administration (FDA)

Pharmaceuticals: Open and Free Legal Research of US Law

Federal Primary Materials

The U.S. federal government system consists of executive, legislative, and judicial branches, each of which creates information that can be the subject of legal research about Pharmaceuticals. This part provides references, in relation to Pharmaceuticals, to the legislative process, the federal judiciary, and the primary sources of federal law (cases, statutes, and regulations).

Federal primary materials about Pharmaceuticals by content types:

Laws and Regulations

US Constitution
Federal Statutory Codes and Legislation

Federal Case Law and Court Materials

U.S. Courts of Appeals
United States courts of appeals, inclouding bankruptcy courts and bankcruptcy appellate panels:

Federal Administrative Materials and Resources

Presidential Materials

Materials that emanate from the President’s lawmaking function include executive orders for officers in departments and agencies and proclamations for announcing ceremonial or commemorative policies. Presidential materials available include:

Executive Materials

Federal Legislative History Materials

Legislative history traces the legislative process of a particular bill (about Pharmaceuticals and other subjects) for the main purpose of determining the legislators’ intent behind the enactment of a law to explain or clarify ambiguities in the language or the perceived meaning of that law (about Pharmaceuticals or other topics), or locating the current status of a bill and monitoring its progress.

State Administrative Materials and Resources

State regulations are rules and procedures promulgated by state agencies (which may apply to Pharmaceuticals and other topics); they are a binding source of law. In addition to promulgating regulations, state administrative boards and agencies often have judicial or quasi-judicial authority and may issue administrative decisions affecting Pharmaceuticals. Finding these decisions can be challenging. In many cases, researchers about Pharmaceuticals should check state agency web sites for their regulations, decisions, forms, and other information of interest.

State rules and regulations are found in codes of regulations and administrative codes (official compilation of all rules and regulations, organized by subject matter). Search here:

State opinions of the Attorney General (official written advisory opinions on issues of state law related to Pharmaceuticals when formerly requested by a designated government officer):

Tools and Forms

Law in Other Regions

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