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How Safe are Generic Drugs?

Author Susan Harr

Generic drugs have been around since the 80s, saving Americans money and making healthcare more affordable for the masses. Nowadays, generic drugs make up 75% of the prescription drug market (according to a Supreme Court report). There is no doubt that generic drugs are cheaper, but at what cost? While the Food and Drug Administration (FDA) assures consumers that the generic drugs are equivalent to their counter-parts, generic drug makers do not follow all of the same rules as name brand manufacturers.

Hatch-Waxman Act

  • Passed in 1984 by Congress
  • Also known as the Drug Price Competition and Patent Term Restoration Act
  • Aimed to “make available more low cost generic drugs by establishing a generic drug approval procedure”
  • Established an abbreviated application process for generic drugs- generic and brand-name drugs must be the same in nearly all respects
  • Allows for generic drug makers to challenge the validity of brand-name drugs' patents before those patents expire

What the FDA says about Generic Drugs Standards

To gain FDA approval, a generic drug must:

  • contain the same active ingredients as the innovator drug (inactive ingredients may vary)
  • be identical in strength, dosage form, and route of administration
  • have the same use indications
  • be bioequivalent
  • meet the same batch requirements for identity, strength, purity, and quality
  • be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products

To stay in compliance, with State and Federal Laws, generic drug makers must:

  • perform tests and show the FDA that their drugs are equivalent in terms of therapeutic effect to the brand-name drug.
  • show that the ingredients of the generic drug enter into the blood stream in the same way and in the same length of time as the brand-name drug.
  • be responsible for monitoring the safety of the drugs (must submit written procedure for doing this to the FDA)
  • report “serious, unexpected” adverse effects to the FDA within 15 days
  • submit yearly reports with any new information that might affect safety

Generic Drug makers DO NOT, however, have to:

  • do testing to show safety/efficacy of their drug, only to show equivalence to the brand name drug
  • change their labels through the FDA’s “Changes-being-effected” process or send out additional warnings

Generic Drug Companies- No Liability

According to the landmark Supreme Court decision made today (June 23, 2011), generic drug companies cannot be sued under state law over allegations that they failed to provide adequate label warnings about potential side effects.

This decision means anyone suffering from injuries stemming from a particular prescription drug, they cannot sue the manufacturer if the drug was prescribed in its generic form.

Contact an Experienced Product Liability Attorney

Thomas J. Henry Injury Attorneys are leaders in the area of product liability litigation. Our Defective Drug and Products Division has extensive knowledge and resources in order to represent our clients efficiently and aggressively. We represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

Your choice does matter. If you or a loved one has suffered serious injuries because of any defective drugs and/or products, call the Thomas J. Henry Injury Attorneys immediately. We are available 24/7, nights and weekends.

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