Bipartisan bill will give DEA broader powers to stop steroids sold as supplements
WASHINGTON — Sens. Orrin Hatch, R-Utah, and Sheldon Whitehouse, D-R.I., on Wednesday introduced the Designer Anabolic Steroid Control Act, a bill that will protect consumers by providing the Drug Enforcement Administration with new enforcement tools to identify and quickly respond when new designer anabolic steroids are created and marketed as dietary supplements.
"This legislation will allow the DEA to target substances whose chemical structures mimic other anabolic steroids and whose manufacturers and marketers promote their anabolic or muscle-building effects and give the DEA new authority to remove them from the market as controlled substances," stated Steve Mister, president and CEO for the Council for Responsible Nutrition. CRN on Wednesday issued its support of the legislation.
In December 2010, CRN, along with four additional dietary supplement trade associations, joined forces with the Food and Drug Administration to raise awareness about the public health problems posed by adulterated products illegally marketed as dietary supplements and heighten enforcement efforts targeting those illegal products. Bodybuilding products unlawfully containing anabolic steroids are one of the categories receiving heightened review by the FDA, Mister noted.
"Misbranded products that contain designer anabolic steroids present serious health risks to consumers, particularly young men who may be unaware of the dangers of anabolic steroid use," Mister said. "When marketers sell new unapproved steroids under the guise of supplements, it is not only dangerous for consumers, but [also] disparages responsible dietary supplement companies producing and selling legitimate, high-quality and beneficial supplements for sports nutrition and performance. We pledge to do what we can to help pass this important legislation.”
Senate committee reports pharmaceutical gray market fueled by unscrupulous pharmacies
WASHINGTON — The Senate Committee on Commerce, Science and Transportation on Wednesday released a staff report on the investigation into the gray market for pharmaceuticals — what the committee defined as "shady operators who make enormous profits by buying hard-to-find drugs and reselling them at huge markups" — specifically naming pharmacies as a primary culprit.
According to the report, gray market drugs "leak" out of authorized distribution chains. "In more than two-thirds (69%) of the 300 drug distribution chains reviewed in the investigation, prescription drugs leaked into the gray market through pharmacies," the report read. "Instead of dispensing the drugs in accordance with their professional duties, state laws, and the expectations of their trading partners, these pharmacies resold the drugs to gray market wholesalers. Some pharmacies sold their entire inventories into the gray market. The wholesalers in turn sold their drugs — usually at significant markups — to other gray market companies."
"There are some unscrupulous dealers who have found a way to make a quick buck at the expense of sick patients, hospitals, and the entire healthcare system," stated Jay Rockefeller IV, D-W.V. "These opportunists have figured out how to exploit the urgency of the healthcare system and buy short-supply drugs with their only intention being to resell them for a big profit. By the time the gray market has done its work, a cancer drug that originally cost $10 can cost $500 or even $1,000. This kind of price gouging is disgusting and indefensible. We need to close down this gray market, and do a better job making sure prescription drugs are safe and affordable."
The National Community Pharmacists Association, in its testimony before the committee, cautioned that a balanced approach needs to be adopted in efforts to augment recently enacted legislation that helps address the prescription drug shortage problem, otherwise patient care could be inadvertently jeopardized.
"We urge Congress to not take actions that might limit the ability of pharmacies to take care of their patients," stated John Coster, NCPA SVP government affairs, in his testimony. “The primary and secondary wholesaler markets both play an important role in ensuring that all patients have seamless access to virtually any product that they may require," he noted. "Having said that, it is unethical for pharmacists to act as a conduit for the illegitimate gray market, which is contrary to the goal of providing the best patient care at the lowest cost. Problems or questionable practices should certainly be investigated and addressed, but any solution needs to be carefully tailored so that the pharmaceutical supply chain is not unduly disrupted and patients do not suffer due to shortages that may occur."
The investigation was launched by Rep. Elijah Cummings, D-Md., last fall and staff from the House and Senate conducted the wide-ranging investigation that resulted in the release of the staff report. The staff report is available here.
Other key findings from the joint congressional investigation:
Gray market companies aggressively mark up drug prices. The markups in the distribution chains often reflect an intent to take advantage of the acute demand for short-supply drugs by charging healthcare providers exorbitant prices. The drugs are significantly marked up, sometimes to prices that are hundreds of times higher than the prices that hospitals and other healthcare providers normally pay;
Gray market companies take advantage of drug shortages. During drug shortages, hospitals are sometimes unable to buy drugs from their normal trading partners, usually one of the three large national "primary" distributors. At the same time, they are deluged by sales solicitations from gray market companies offering to sell the shortage drugs for prices that are often hundreds of times higher than the prices they normally pay. Hospital pharmacists reluctantly pay gray market distributors for life-saving drugs needed to treat patients;
"Fake pharmacies" acquire prescription drugs from authorized distributors and then sell them into the gray market. The investigation has identified a number of businesses holding pharmacy licenses that appear to operate for the sole purpose of acquiring short-supply drugs that can be sold into the gray market; and
"Drug brokers" recruit pharmacies to purchase drugs for the gray market. Some gray market wholesalers gain access to shortage drugs by engaging third-party brokers to recruit pharmacies to act as their purchasing agents.
NCPA offered the following recommendations to the committee:
Pharmacies should be allowed to continue returning outdated or short-dated products to wholesalers or distributors, or products that were sent to the pharmacy in error;
Pharmacies also should be allowed to continue selling pharmaceutical products to other pharmacies, because it helps to alleviate temporary shortages, especially in rural areas where daily wholesaler deliveries may be more sporadic; and
Uniformly raise the bar for all entities engaged in this line of business and encourage all participants in the supply chain to perform the appropriate due diligence.
RxAlly appoints Wayne Oliver as VP pharmacy advocacy and government relations
LEESBURG, Va. — An alliance of more than 22,000 pharmacies has added a new member to its leadership team.
RxAlly announced the appointment of Wayne Oliver as VP pharmacy advocacy and government relations, a role in which he will serve as a liaison between RxAlly and various levels of government.
Oliver has previously served as a consultant with politicians and other leaders and was previously VP at the Center for Health Transformation, an organization founded by former House of Representatives speaker Newt Gingrich, as well as the lead lobbyist and spokesman for the Georgia Pharmacy Association and managing editor of the Georgia Pharmacy Journal.