Campaign Promises

Departments -> Health & Human Services -> Pharmaceuticals

ItemHealth & Human Services
PharmaceuticalsGrade
HE-46 The Promise: "Prevent drug companies from blocking generic drugs from consumers...will work to ensure that market power does not lead to higher prices for consumers.."
When/Where: Obama-Biden Plan: "To Lower Health Care Costs and Ensure Affordable, Accessible Health Coverage For All," dated 10/03/08.
Source: http://mendocinohre.org/rhic/200812/HealthCareFullPlan.pdf
Status:For decades, some brand-name drug manufacturers have resorted to "product switching" or "product hopping" tactics designed to delay or prevent entirely the entry of generic drugs into the market, thereby protecting their market shares.

Reportedly, brand name drug manufacturers have benefited from price fixing deals (reverse payment agreements to protect patent holders) with generic drug manufacturers to delay the entry of generic drugs on the market, as authorized under the Drug Price Competition and Patent Term Restoration Act of 1984.

The Patient Protection and Affordable Care Act (ACA) of 2009 included a provision mandating that the Secretary of Health and Human Services shall "facilitate generic substitution when a generic covered outpatient drug is available at a lower price" but fell far short of preventing brand name drug manufacturers from blocking generic drug manufacturers. In fact, the Section 7002 of the ACA protects the brand name drug manufacturers by stipulating that applications for generic (biosimilar) drugs "may not be made effective by the Secretary until the date that is 12 years after the date on which the reference product was first licensed...".

President Obama's FY2010 budget proposal included language "prohibiting anticompetitive agreements and collusion between brand name and generic drug manufacturers intended to keep generic drugs off the market" and prohibiting drug manufacturers from "reformulating existing products into new products."

Several bills to codify the objective of this promise were introduced in Congress since CY2009. On 09/22/15, Senator Amy Klobuchar (D-MN) introduced a new iteration of the "Preserve Access to Affordable Generics Act" (S.2019) which had as its purpose: "(1) to enhance competition in the pharmaceutical market by stopping anticompetitive agreements between brand name and generic drug manufacturers that limit, delay, or otherwise prevent competition from generic drugs; and (2) to support the purpose and intent of antitrust law by prohibiting anticompetitive practices in the pharmaceutical industry that harm consumers." This bill was not enacted before the 114th Congress expired at the end of CY2016.

This promise was not fulfilled.		0.00
HE-47 The Promise: "... will allow Americans to buy their medicines from other developed countries if the drugs are safe and prices are lower outside the U.S."
When/Where: Obama-Biden Plan: "To Lower Health Care Costs and Ensure Affordable, Accessible Health Coverage For All," dated 10/03/08.
Source: http://mendocinohre.org/rhic/200812/HealthCareFullPlan.pdf
Status:In return for pledges by the pharmaceutical companies to put up $80B over 10 years in pledged drug cost reductions, it appeared that the White House had assented to move away from permitting the importation of cheaper drugs from developed countries such as Canada.

On 12/20/09, however, the White House reaffirmed President Obama's commitment to allow the re-importation of drugs initially produced in the U.S., exported, then imported back into the country at a lower cost than the same drug costs in the U.S.

Neither the Patient Protection and Affordable Care Act of 2010 nor the Health Care and Education Reconciliation Act of 2010 mentioned any authorization to reimport drugs from such developed countries as Canada.

Back on 10/28/00, provisions of the "Medicine Equity and Drug Safety Act" (MEDSA) and the "Prescription Drug Import Fairness Act" were signed into law by President Bill Clinton as incorporated into the "Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2001" (H.R. 4461) as Sections 745 and 746 respectively. This law permitted the importation of safe and cost effective pharmaceuticals into the USA from high-income countries such as Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa and the European Union so long as the Secretary of Health and Human Services (HHS) certified that there was no additional risk to the purchaser and that the importation would result in "significant" savings to purchasers.

As of end-CY2016, the cited provisions of the above law had not been implemented by any Secretaries of HHS of the Obama Administrations or preceding administrations.

This promise was not fulfilled.		0.00