• Regulatory NewsRegulatory News

    India Looks to Cap Prices of 12 Cancer Drugs as Nation Looks to Expand Price Controls

    The cost of 12 cancer drugs could soon be capped in India if a recommendation from the country's National Pharmaceutical Pricing Authority (NPPA) is approved, The Indian Express reports. At the same time, the government is actively looking into revising its National List of Essential Medicines (NLEM) following a proposal from a parliamentary committee for price caps to be extended to all drugs two weeks ago. Background In India, the prices of drugs listed under t...
  • Regulatory NewsRegulatory News

    Indian Parliament Proposes Extending Price Caps to all Drugs

    Just weeks after India's drug pricing chief was ousted, a parliamentary committee has proposed expanding price caps to all drugs. Background In India, the price of drugs listed as essential medicines is capped by the National Pharmaceutical Pricing Authority (NPPA) under the country's Drug Price Control Order (DPCO) . The amount these drugs can be sold for is indexed to average wholesale prices of similar products, and can only be increased once per year, as was th...
  • RAPSRAPS' Latest

    Next RAPS Virtual Career Fair Coming Up 23 April

    The next RAPS Virtual Career Fair will take place on Thursday, 23 April 2015, from 12 to 4:30 pm EDT. This virtual event brings together hiring managers and recruiters from leading healthcare organizations with regulatory job seekers in an interactive online job fair. Using an online platform, job seekers can chat in real time with representatives from companies that are hiring now, submit resumes and respond to multiple job openings securely and easily. Registrati...
  • Regulatory NewsRegulatory News

    FDA Considers Allowing Drug Companies to Drop Some Warnings in TV Commercials

    The US Food and Drug Administration (FDA) has announced its plans to study whether consumers would benefit if direct-to-consumer television advertising contained a shorter list of major side effects instead of the now-lengthy list of nearly all of them. Background The study, first proposed in February 2014, is meant to address a regulatory hypothesis: That consumers, bombarded with a long list of side effects, might have a difficult time deciding between drugs. In the s...
  • Regulatory NewsRegulatory News

    Bill Would Close Loopholes Now Preventing Some Generic Drugs From Being Approved

    A new bill introduced last week would seek to limit the use of safety programs required by the US Food and Drug Administration (FDA) to delay and even prevent the introduction of generic drugs into the market. Background REMS were first introduced under the 2007 Food and Drug Administration Amendments Act (FDAAA) , and were meant to act as a regulatory hedge against potentially risky products. REMS typically include the following elements: A communication plan, Medicat...
  • FDA Expresses Interest in Comparative Price of Drugs (But not in the way you Think)

    Watch a drug advertisement in the US-any one, really-and one thing you're unlikely to hear any mention of is the drug's cost. That's not always an accident, as the myriad of insurance companies, co-pays, state insurance programs, private assistance programs, coupons and other incentives mean that the true cost of a drug is rarely seen by consumers and is rarely the same for two people. But assume, for a moment, that such an instance existed-that a drug ("Drug A") cost ...
  • OPDP Releases Third Untitled Letter in as Many Weeks

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has issued a warning to US WorldMeds regarding the online marketing of one of its drugs, Revonto, calling claims made by the company misleading and unsubstantiated. Background The warning, known as an Untitled Letter, is the third posted by OPDP since 24 October. Affected companies include Sunovion Pharmaceutical and Daiichi Sankyo, while a fourth, Aegerion Pharmaceuticals, was sent...
  • J&J's Janssen Gets Second Untitled Letter in as Many Months as FDA Targets Xarelto Advertising Piece

    On Wednesday, the US Food and Drug Administration (FDA) released the text of a new Untitled Letter sent to Johnson & Johnson - the second sent in as many months to the same company - regarding promotional material for its blockbuster anticoagulant Xarelto (rivaroxaban), alleging that the company failed to present the risks of the drug in a fair and balanced manner. Background: Doxil Untitled Letters are less serious than the more widely-known Warning Letters, whic...
  • Ireland Implements Reference Pricing to Boost Use of Generics

    The Health (Pricing and Supply of Medical Goods) Act of 2013, enacted in Ireland on 28 May 2013, introduces a system of generic substitution and reference pricing for medicinal products in Ireland. The Irish Medicines Board (IMB) has published guidance detailing its responsibilities under the Act and the process for creating the mandated List of Interchangeable Medicines. Reference pricing involves the setting of a common reimbursement price, or reference price, for a...
  • India's Drug Pricing Authority Announces Stiff Fines for Violators of Price Limits

    India's National Pharmaceutical Pricing Authority (NPPA) has released a new guideline indicating that companies that overcharge Indian consumers may be liable for recovery damages as high as the entirety of the product's sales in the country. The guideline, dated 12 October 2012, explains that it believes, "It is absolutely essential that manufacturers and marketing companies should not sell their scheduled formulations at unauthorized and illegitimate prices to earn u...
  • Study: OTC Drug Advertising Lacks Sufficient Balance of Risks, Benefits

    Advertisements for over-the-counter (OTC) pharmaceutical products routinely discount the risks associated with a product instead of presenting the same "fair balance" approach mandated for prescription products, say researchers. Writing in the Journal of the American Medical Association (JAMA) , lead researcher Jeremy Greene explained that often when prescription drugs achieve OTC status, the drug's risks disappear from the advertising. "A commitment to fair balan...
  • RAPSRAPS' Latest

    Next RAPS Virtual Career Fair: 17 May

    The Regulatory Affairs Professionals Society (RAPS) will host its next Virtual Career Fair on Thursday, 17 May, from 10 am-6 pm EDT. RAPS members can enter the fair at 9 am-one hour ahead of the general public-to gain exclusive access to recruiters. The virtual event is an interactive online job fair for regulatory jobseekers and companies looking to fill open regulatory positions. Through the Virtual Career Fair portal, jobseekers can submit resumes and respond to multip...